Medical appliance system, monitor device, and method of monitoring a medical appliance

ABSTRACT

A monitor device for an ostomy system comprising an ostomy appliance with a base plate and a method of monitoring an ostomy appliance is disclosed. The monitor device comprises a processor configured to apply a processing scheme; memory; a first interface connected to the processor and the memory, the first interface configured for collecting ostomy data from the base plate coupled to the first interface; and a second interface connected to the processor, wherein to apply a processing scheme comprises: obtain first parameter data, second parameter data, and third parameter data based on the ostomy data; and determine an operating state of the base plate of the ostomy appliance based on the first parameter data, the second parameter data and the third parameter data, wherein the operating state is indicative of a degree of radial erosion of the base plate and/or acute leakage risk for the ostomy appliance, wherein the monitor device is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.

The present disclosure relates to an ostomy appliance system, devicesthereof and method for monitoring an ostomy appliance. The ostomyappliance system comprises an ostomy appliance and a monitor device. Inparticular, the present disclosure relates to detection and monitoringof operating state for a base plate including degrees or erosion and/orswelling of an adhesive layer of the base plate. A monitor device for anostomy system comprising an ostomy appliance with a base plate isdisclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8 ,

FIG. 10 is a distal view of a part of the base plate including monitorinterface,

FIG. 11 is a graphical presentation of parameter data,

FIG. 12 is a flow diagram of an exemplary method,

FIG. 13 is a flow diagram of an exemplary method,

FIG. 14 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 15 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 16 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 17 is an exemplary graphical representation of parameter data as afunction of time and a whitening zone diameter as a function of time,

FIGS. 18A-18B are exemplary graphical representations of peel force as afunction of a peeling distance travelled by a peeling action exercisingthe peel force on a first adhesive layer of a base plate.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

A radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre.

An ostomy system comprising an ostomy appliance and a monitor device,the ostomy appliance comprising a base plate is disclosed, wherein themonitor device is a monitor device as described herein.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of erosion and/or swelling in theadhesive material provided for attaching the base plate to the skinsurface of a user. Depending on the nature of the erosion/swellingpattern in the adhesive, the ostomy system and devices thereof enableproviding information to the user about the operating state of the baseplate, and in turn enable providing an indication to the user of theseverity and thus the remaining time frame for replacing the ostomyappliance without experiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

A base plate for an ostomy appliance is disclosed, the base platecomprising a first adhesive layer with a proximal side configured forattachment of the base plate to the skin surface of a user, the firstadhesive layer having a stomal opening with a center point; and aplurality of electrodes including a ground electrode, a first electrode,and a optionally a second electrode, the ground electrode comprising aground connection part, the first electrode comprising a firstconnection part, and the second electrode comprising a second connectionpart, wherein the ground electrode forms a ground for the firstelectrode and/or the second electrode.

The base plate comprises a first adhesive layer. During use, the firstadhesive layer adheres to the user's skin (peristomal area) and/or toadditional seals, such as sealing paste, sealing tape and/or sealingring. Thus, the first adhesive layer may be configured for attachment ofthe base plate to the skin surface of a user. The first adhesive layerhas a stomal opening with a center point or is at least prepared forforming a stomal opening with a center point. A base plate with threeelectrodes having sensing parts with contact to the first adhesive layerallows for determining erosion/swelling properties or characteristics ofthe first adhesive layer and/or determining a degree of erosion and/orswelling of the first adhesive layer.

It is an advantage of the present disclosure that an optimum or improveduse of an ostomy appliance is provided. In particular, the presentdisclosure facilitates that a base plate is not changed too early(leading to increased cell-stripping from the skin and increased risk ofskin damage and further leading to increased costs and/or materialwaste) nor too late (leading to adhesive failure, leakage and/or skindamage from the aggressive output). Accordingly, the user or a healthcare professional is able to monitor and plan the use of the ostomyappliance.

Further, determination of erosion/swelling and classification ofoperating states of the ostomy appliance is useful in helping to reducethe risk of a user experiencing leakage from an ostomy appliance.Further, determination of degrees of erosion/swelling and classificationof operating states of the ostomy appliance is further useful in helpingreduce the risk of skin damage to a user. In particular, determinationof degrees of erosion and/or swelling according to the presentdisclosure may help provide a clear distinction or differentiationbetween adhesive failure, leakage of output, which is harmful to theskin, and a sweating ostomate.

Thus, determination of operating state and classification of operatingstates of the ostomy appliance is useful in helping to reduce the riskof a user experiencing leakage from an ostomy appliance. Further,determination of operating state and classification of operating statesof the ostomy appliance is further useful in helping reduce the risk ofskin damage to a user. In particular, determination of operating stateaccording to the present disclosure may help provide a clear distinctionor differentiation between adhesive failure, leakage of output, which isharmful to the skin, and a sweating ostomate.

The present disclosure provides a simple, efficient, and easy-to-useostomy appliance system with a high degree of comfort for a user.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocolloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids, and synthetic hydrocolloids. The firstcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethyl cellulose (CMC). The first composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is configured tooverlap a (sensing) part of an electrode, e.g. to form a sensor point.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap (sensing) parts of an electrode and theprimary second sensor point openings configured to overlap (sensing)parts of another electrode different from the electrode at least partlyoverlapped by the primary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap (sensing) parts of an electrode andthe secondary second sensor point openings configured to overlap(sensing) parts of another electrode different from the electrode atleast partly overlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap (sensing) parts of an electrode andthe tertiary second sensor point openings configured to overlap(sensing) parts of another electrode different from the electrode atleast partly overlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate may comprise a second layer. The second layer may be anadhesive layer. The second layer may have a second radial extension thatis larger than a first radial extension of the first adhesive layer atleast in a first angular range of the base plate. Accordingly, a part ofa proximal surface of the second layer may be configured for attachmentto the skin surface of a user. The part of a proximal surface of thesecond layer configured for attachment to the skin surface of a user isalso denoted the skin attachment surface of the second adhesive layer.The second layer may have a stomal opening with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocolloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids, and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethyl cellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocolloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively, or additionally,the second adhesive layer may be thinner than the first adhesive layer.Alternatively, or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively, or additionally, the second adhesive layer may be lessmoldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate comprises one or more electrodes, such as a plurality ofelectrodes, such as two, three, four, five, six, seven or moreelectrodes. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the second adhesive layer.The electrodes may be arranged in an electrode assembly, e.g. anelectrode layer. An electrode comprises a connection part for connectingthe electrodes to other components and/or interface terminals/terminalelements. An electrode may comprise one or more conductor parts and/orone or more sensing parts. The electrode assembly may be arrangedbetween the first adhesive layer and the second adhesive layer. The baseplate, e.g. the electrode assembly, may comprise a first electrode, asecond electrode and optionally a third electrode. The base plate, e.g.the electrode assembly, may comprise a fourth electrode and/or a fifthelectrode. The base plate, e.g. the electrode assembly, optionallycomprises a sixth electrode. The base plate, e.g. the electrodeassembly, may comprise a ground electrode. The ground electrode maycomprise a first electrode part. The first electrode part of the groundelectrode may form a ground or reference for the first electrode. Theground electrode may comprise a second electrode part. The secondelectrode part of the ground electrode may form a ground or referencefor the second electrode. The ground electrode may comprise a thirdelectrode part. The third electrode part of the ground electrode mayform a ground or reference for the third electrode. The ground electrodemay comprise a fourth electrode part. The fourth electrode part of theground electrode may form a ground or reference for the fourth electrodeand/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

The ground electrode may comprise a first electrode part and a secondelectrode part, the first electrode part forming the ground for thefirst electrode and the second electrode part forming the ground for thesecond electrode. The first electrode part may form a closed loop.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair. The fourth electrode and the fifthelectrode may form a sixth sensor or sixth electrode pair. In one ormore embodiments, the electrode assembly comprises the fourth electrodepair, the fifth electrode pair, and/or the sixth electrode pair.

An electrode may comprise a sensing part or a plurality of sensingparts, i.e. the part(s) of an electrode that are used for sensing. Thefirst electrode may comprise a first sensing part. The first sensingpart may contact the first adhesive layer and is optionally arranged atleast partly annularly around the stomal opening. The first electrodemay comprise a first conductor part insulated from the first adhesivelayer, e.g. by a masking element arranged between the first conductorpart and the first adhesive layer. The first sensing part may extend atleast 270 degrees around the stomal opening, such as at least 300degrees around the stomal opening. The first sensing part of the firstelectrode may be arranged at a first ground distance from the firstelectrode part of the ground electrode. The first ground distance may beless than 5 mm, such as less than 3 mm, e.g. about 1.0 mm.

The second electrode may comprise a second sensing part. The secondsensing part may contact the first adhesive layer. The second sensingpart may be arranged at least partly annularly around the stomalopening. The second sensing part may extend at least 270 degrees aroundthe stomal opening, such as at least 300 degrees around the stomalopening. The second sensing part of the second electrode may be arrangedat a second ground distance from the second electrode part of the groundelectrode. The second ground distance may be less than 5 mm, such asless than 3 mm, e.g. about 1.0 mm.

The first sensing part may be arranged at a first radial distance fromthe center point and the second sensing part may be arranged at a secondradial distance from the center point. The second radial distance may belarger than the first radial distance. The second electrode may comprisea second conductor part insulated from the first adhesive layer, e.g. bya masking element arranged between the second conductor part and thefirst adhesive layer. The first radial distance may vary as a functionof an angular position with respect to a zero direction from the centerpoint. The second radial distance may vary as a function of an angularposition with respect to a zero direction from the center point. Thezero direction may be defined as the vertical upward direction when thebase plate is in its intended wearing position on an upstanding user.

The first radial distance may be in the range from 5 mm to 40 mm, suchas in the range from 10 mm to 25 mm, e.g. about 14 mm. The second radialdistance may be in the range from 10 mm to 50 mm, such as in the rangefrom 10 mm to 25 mm, e.g. about 18 mm.

The base plate may comprise a third electrode comprising a thirdconnection part. The ground electrode may form a ground for the thirdelectrode. The ground electrode may comprise a third electrode part, thethird electrode part forming the ground for the third electrode. Thethird electrode may comprise a third conductor part insulated from thefirst adhesive layer, e.g. by a masking element arranged between thethird conductor part and the first adhesive layer. The third electrodemay comprise a third sensing part, the third sensing part contacting thefirst adhesive layer. The third sensing part may be arranged at leastpartly annularly around the stomal opening. The third sensing part maybe arranged at a third radial distance from the center point. The thirdradial distance may be larger than the first radial distance and/orlarger than the second radial distance. The third radial distance may bein the range from 15 mm to 50 mm. such as in the range from 20 mm to 30mm, e.g. about 26 mm. The third sensing part may extend at least 270degrees around the stomal opening, such as at least 300 degrees aroundthe stomal opening. The third sensing part of the third electrode may bearranged at a third ground distance from the third electrode part of theground electrode. The third ground distance may be less than 5 mm, suchas less than 3 mm, e.g. about 1.0 mm. A base plate with a groundelectrode, a first electrode, a second electrode, and a third electrodeallows for a failsafe base plate in case e.g. the first electrode is cutor otherwise destroyed during preparation of the base plate.

The base plate may comprise a fourth electrode comprising a fourthconnection part. The ground electrode may form a ground for the fourthelectrode. The ground electrode may comprise a fourth electrode part,the fourth electrode part forming the ground for the fourth electrode.The fourth electrode may comprise one or a plurality of fourth sensingparts, such as at least five fourth sensing parts. The fourth sensingparts may be distributed around the stomal opening or a center pointthereof. The fourth sensing parts may be arranged at respective fourthradial distances from the center point. The fourth radial distance(s)may be larger than the third radial distance. The fourth radialdistance(s) may be in the range from 25 mm to 50 mm, such as about 30 mm

The base plate may comprise a fifth electrode comprising a fifthconnection part. The ground electrode may form a ground for the fifthelectrode. The ground electrode may comprise a fifth electrode part, thefifth electrode part forming the ground for the fifth electrode. Thefifth electrode may comprise one or a plurality of fifth sensing parts,such as at least five fifth sensing parts. The fifth sensing parts maybe distributed around the stomal opening or a center point thereof. Thefifth sensing parts may be arranged at respective fifth radial distancesfrom the center point. The fifth radial distance may be larger than thethird radial distance. The fifth radial distance may be equal to orlarger than the fourth radial distance. The fifth radial distance(s) maybe in the range from 25 mm to 50 mm, such as about 30 mm.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The base plate may comprise a second adhesive layer, wherein theplurality of electrodes is arranged between the first adhesive layer andthe second adhesive layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Thus, oneor more electrodes may be arranged between the support layer and thefirst adhesive layer. The electrode assembly may have a stomal openingwith a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates, the support layer is made of thermoplasticpolyurethane (TPU). The support layer material may be made of orcomprise one or more of polyester, a thermoplastic elastomer (TPE),polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, andsilicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The electrode assembly/base plate may comprise a masking elementconfigured to insulate at least parts of the electrodes from the firstadhesive layer of the base plate. The masking element may comprise oneor more, such as a plurality of, sensor point openings. The sensor pointopenings may comprise primary sensor point openings and/or secondarysensor point openings. The sensor point openings may comprise tertiarysensor point opening(s). The sensor point openings may comprisequaternary sensor point opening(s). A sensor point opening of themasking element overlaps at least one electrode of the electrodeassembly when seen in the axial direction, e.g. to form a sensor point.For example, a primary sensor point opening may overlap a (sensing) partof the ground electrode and/or a (sensing) part of the fourth electrode.A secondary sensor point opening may overlap a (sensing) part of thefourth electrode and/or a (sensing) part of the fifth electrode. Atertiary sensor point opening may overlap a (sensing) part of the fifthelectrode and/or a (sensing) part of the ground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. A terminal opening may overlap with one or moreconnection parts of electrodes. In one or more exemplary base plates,each terminal opening overlaps with a single connection part of anelectrode.

The masking element may comprise polymeric (e.g. polyurethane, PTFE,PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates, the masking element is made of or comprisesthermoplastic polyurethane (TPU). In one or more exemplary base plates,the masking element is made of or comprises polyester. The maskingelement material may be made of or comprise one or more of polyester, athermoplastic elastomer (TPE), polyimide, polyimide, Ethylene-vinylacetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate may comprise a first intermediate element. The firstintermediate element may be arranged between the electrodes/electrodelayer and the first adhesive layer and/or between the second layer andthe first adhesive layer. The first intermediate layer may be made of aninsulating material.

The base plate may comprise a release liner. The release liner is aprotective layer that protects adhesive layer(s) during transport andstorage and is peeled off by the user prior to applying the base plateon the skin. The release liner may have a stomal opening with a centerpoint.

The base plate may comprise a top layer. The top layer is a protectivelayer protecting the adhesive layer(s) from external strains and stresswhen the user wears the ostomy appliance. The electrodes, e.g. some orall the electrodes, may be arranged between the first adhesive layer andthe top layer. The top layer may have a stomal opening with a centerpoint. The top layer may have a thickness in the range from 0.01 mm to1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm. Thetop layer may have a stomal opening with a center point.

The base plate comprises a monitor interface. The monitor interface maybe configured for electrically and/or mechanically connecting the ostomyappliance (base plate) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (baseplate) to the monitor device. Thus, the monitor interface of the baseplate is configured to electrically and/or mechanically couple theostomy appliance and the monitor device.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a coupling part for forming amechanical connection, such as a releasable coupling between the monitordevice and the base plate. The coupling part may be configured to engagewith a coupling part of the monitor device for releasably coupling themonitor device to the base plate.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a plurality of terminals, suchas two, three, four, five, six, seven or more terminals, for formingelectrical connections with respective terminals of the monitor device.The monitor interface may comprise a ground terminal element forming aground terminal. The monitor interface may comprise a first terminalelement forming a first terminal, a second terminal element forming asecond terminal and optionally a third terminal element forming a thirdterminal. The monitor interface may comprise a fourth terminal elementforming a fourth terminal and/or a fifth terminal element forming afifth terminal. The monitor interface optionally comprises a sixthterminal element forming a sixth terminal. The terminal elements of themonitor interface may contact respective electrodes (connection parts)of the base plate/electrode assembly. The first intermediate element maybe arranged between the terminal elements and the first adhesive layer.The first intermediate element may cover or overlap terminal element(s)of the base plate when seen in the axial direction. Thus, the firstadhesive layer may be protected or experience more evenly distributedmechanical stress from the terminal elements of the base plate, in turnreducing the risk of terminal elements penetrating or otherwise damagingthe first adhesive layer. The first intermediate element may protect ormechanically and/or electrically shield the first adhesive layer fromthe terminal elements of the base plate.

A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal end and a proximalend. A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal part, a centre part,and/or a proximal part. The distal part may be between the distal endand the centre part. The proximal part may be between the proximal endand the centre part. The proximal end/proximal part of a terminalelement may contact a connection part of an electrode. A terminalelement, such as the ground terminal element, the first terminalelement, the second terminal element, the third terminal element, thefourth terminal element, the fifth terminal element and/or the sixthterminal element, may be gold plated copper.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate has a stomal opening with a center point. The size and/orshape of the stomal opening is typically adjusted by the user or nursebefore application of the ostomy appliance to accommodate the user'sstoma. In one or more exemplary base plates, the user forms the stomalopening during preparation of the base plate for application.

A monitor device for an ostomy system comprising an ostomy appliancewith a base plate is disclosed, the monitor device comprising aprocessor configured to apply a processing scheme; memory; a firstinterface connected to the processor and the memory, the first interfaceconfigured for collecting ostomy data from the base plate coupled to thefirst interface, the ostomy data comprising one or more, such as all, offirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, andoptionally third ostomy data from a third electrode pair of the baseplate; and a second interface connected to the processor. To apply aprocessing scheme comprises obtain first parameter data based on thefirst ostomy data; obtain second parameter data based on the secondostomy data; and optionally obtain third parameter data based on thethird ostomy data. To apply a processing scheme comprises determine anoperating state of the base plate of the ostomy appliance. To determinethe operating state of the base plate may be based on one or more, suchas all, of the first parameter data, the second parameter data, thethird parameter data, and fourth parameter data. The operating state maybe indicative of a degree of radial erosion and/or radial swelling ofthe base plate, such as of the first adhesive layer, and/or an acuteleakage risk for the ostomy appliance. The monitor device may beconfigured to transmit a monitor signal comprising monitor dataindicative of the determined operating state of the base plate via thesecond interface. The monitor device may be configured to, in accordancewith a determination that the operating state is a first operatingstate, transmit a first monitor signal comprising monitor dataindicative of the first operating state of the base plate via the secondinterface. The monitor device may be configured to, in accordance with adetermination that the operating state is a second operating state,transmit a second monitor signal comprising monitor data indicative ofthe second operating state of the base plate via the second interface.

An operating state in the present disclosure is indicative of thedynamic internal state of the ostomy appliance (e.g. of the base plateof the ostomy appliance currently being worn by the user) optionallyrelated to adhesive performance of the ostomy appliance. Adhesiveperformance of the ostomy appliance may be related to an internalcondition of the ostomy appliance (e.g. of the base plate of the ostomyappliance), such as an internal condition of an adhesive layer of theostomy appliance. The adhesive performance, and thereby the operatingstate may be affected by several factors, such as humidity, temperature,misplacement of the ostomy appliance on the stoma, and/or malfunction ofthe ostomy appliance. The one or more factors alone or in combinationimpact the adhesive performance of the ostomy appliance. The operatingstate may be varying in time. The operating state may be indicative of adegree of erosion of the base plate.

Adhesive performance may be indicative of wear property, e.g. wear timeand/or wear comfort. The operating state may comprise at least one of: awear time, a quality of adhesion, and a moisture pattern representation.Wear time may comprise average wear time, nominal wear time, minimalwear time, maximal wear time, median wear time, and/or any of otherstatistical metric derivable from wear time. Wear time may compriseremaining wear time and/or current wear time and/or elapsed wear time. Aquality of adhesion may comprise a metric indicative of erosion of alayer of the base plate, such as of the first adhesive layer. A moisturepattern representation may comprise one or more metrics or parametersrepresentative or indicative of a moisture pattern (e.g. a moisturepattern type), e.g. a moisture pattern of the first adhesive layer.

An operating state may be configured to indicate whether the ostomyappliance is properly operational based on its adhesive performance(e.g. wear property, e.g. wear time and/or wear comfort). For example,the operating state may be indicative of the severity and/or imminenceof a leakage (e.g. low, medium, high or acute).

In one or more exemplary monitor devices, the first operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a first degree of radial erosionand/or radial swelling, e.g. the first adhesive layer is eroded orswelled to the first radial distance of the first electrode pair but notto the second radial distance of the second electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a second degree of radialerosion and/or radial swelling, e.g. the first adhesive layer is erodedor swelled to the second radial distance of the second electrode pairbut not to the third radial distance of the third electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data. In one ormore exemplary monitor devices, determination of an operating state maybe based on one or more fourth parameters, such as fourth primaryparameter and/or fourth secondary parameter of the fourth parameterdata.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface connected to theprocessor. The first interface may be configured as an applianceinterface for electrically and/or mechanically connecting the monitordevice to the ostomy appliance. Thus, the appliance interface isconfigured to electrically and/or mechanically couple the monitor deviceand the ostomy appliance. The first interface may be configured as anaccessory device interface for electrically and//or mechanicallyconnecting the monitor device to an accessory device, such as a dockingstation. The first interface may be configured for coupling to a dockingstation of the ostomy system, e.g. for charging the monitor deviceand/or for data transfer between the monitor device and the dockingstation.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensors.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively. The processor may be configured totransmit a monitor signal, such as third monitor signal and/or fourthmonitor signal via the loudspeaker. The processor may be configured totransmit a monitor signal, such as one or more, e.g. all, of firstmonitor signal, second monitor signal, third monitor signal, fourthmonitor signal and default monitor signal, as a wireless monitor signalvia the antenna and the wireless transceiver.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate of the ostomy appliance.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively. The first parameter data, the second parameter data, andthe third parameter data may be indicative of voltage between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively (and thus indicative of resistance). The first parameterdata, the second parameter data, and the third parameter data may beindicative of current between the first electrode pair, the secondelectrode pair, and the third electrode pair, respectively (and thusindicative of resistance).

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively. In one or more exemplary monitordevices, the first parameter data, the second parameter data, and thethird parameter data may be indicative of a rate of change in voltagebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively. In one or more exemplary monitordevices, the first parameter data, the second parameter data, and thethird parameter data may be indicative of a rate of change in currentbetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

To determine an operating state of the base plate of the ostomyappliance may comprise to determine an operating state from a set ofoperating states. In other words, to determine an operating state maycomprise selecting an operating state from a set of predefined operatingstates. The set of predefined operating states may comprise a number ofoperating states, such as at least two operating states, at least threeoperating states, at least four operating states, at least fiveoperating states. The number of operating states may be in the rangefrom four to twenty. In one or more exemplary monitor devices, thenumber of operating states in the set of predefined operating states. islarger than ten, such as larger than 20 or even larger than 50.

In one or more exemplary monitor devices, the processor is configured todetermine an operating state of the base plate if a change criterion isfulfilled. The change criterion may be based on the first parameterdata, the second parameter data and/or the third parameter data. Thechange criterion may be fulfilled if parameter data changes, e.g. if achange in parameter data is larger than a change threshold. Thus,operating state determination may be conditional or dependent on achange in the parameter data, in turn leading to an optimum use of poweror battery resources in the monitor device, since operating statedetermination is only performed when there may be a change in theoperating state as a consequence of the change in parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a first criteria set based on thefirst parameter data and/or the second parameter data, wherein theoperating state is determined to be the first operating state if thefirst criteria set is satisfied. The first criteria set may comprise oneor more first criteria based on one or more of first parameter data,second parameter data and third parameter data. The first criteria setmay comprise a first primary criterion based on the first parameterdata. The first criteria set may comprise a first secondary criterionbased on the second parameter data. The first criteria set may comprisea first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate may be based on a first threshold set comprisingone or a plurality of first threshold values. The first threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the first criteria set. The first threshold set may comprise a firstprimary threshold value. The first threshold set may comprise a firstsecondary threshold value. The first threshold set may comprise a firsttertiary threshold value.

The first criteria set may be given by or at least may comprise(P_1_1<TH_1_1),(P_2_1>TH_1_2), and(P_3_1>TH_1_3),wherein P_1_1 is a first primary parameter based on the first parameterdata, TH_1_1 is a first primary threshold value, P_2_1 is a secondprimary parameter based on the second parameter data, TH_1_2 is a firstsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data, and TH_1_3 is a first tertiary thresholdvalue, and wherein the first operating state is indicative of low degreeof radial erosion or radial swelling on the base plate. The firstthreshold values (TH_1_1, TH_1_2 and TH_1_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate. The first tertiary criterion (P_3_1<TH_1_3) may be omitted in thefirst criteria set. The first operating state, e.g. indicative of lowdegree of radial erosion or swelling on the base plate may be indicativeof a radial progression of moisture to the first electrode pair (but notto the second electrode pair and not to the third electrode pair) whichcorresponds to e.g. an un-alarming and/or normal radial progression ofmoisture.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the firstthreshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to firstresistance threshold values. In one or more exemplary embodiments, thefirst primary threshold value TH_1_1 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplaryembodiments, the first secondary threshold value TH_1_2 may correspondto the upper resistance threshold value. In one or more exemplaryembodiments, the first tertiary threshold value TH_1_3 may correspond tothe upper resistance threshold value.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate. The first parameterdata may comprise a first secondary parameter which may be derived fromthe first primary parameter, and/or a first tertiary parameter, whichmay be derived from the first primary parameter. A first secondaryparameter P_1_2 may comprise or be a gradient derived from the firstprimary parameter/first parameter data. In one or more embodiments, afirst primary parameter P_1_1 may be indicative of a voltage between thefirst electrode pair (first electrode and first electrode part of theground electrode) of the base plate.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the firstthreshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to firstvoltage threshold values. In one or more exemplary embodiments, thefirst primary threshold value TH_1_1 may correspond to an upper voltagethreshold value. An upper voltage threshold value may be set to a valueless than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or moreexemplary embodiments, the first secondary threshold value TH_1_2 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the first tertiary threshold value TH_1_3 maycorrespond to the upper voltage threshold value.

The first criteria set may comprise e.g.(P_4_1>TH_1_4)wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance, voltage, or currentbetween the fourth electrode pair and TH_1_4 is a first quaternarythreshold value, and wherein the first operating state is indicative ofabsence of fluid on the proximal side of the first adhesive layer of thebase plate of the ostomy appliance. In one or more exemplaryembodiments, the first quaternary threshold value TH_1_4 may correspondto an upper resistance threshold value. An upper resistance thresholdvalue may be set to a value which is less than 30 Mega-Ohms, such as 25Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the following additional criterionmay be determined(P_1_1<TH_low),wherein P_1_1 is a first primary parameter based on the first parameterdata, TH_low is a threshold value corresponding to a lower resistancethreshold value. In one or more exemplary embodiments, a lowerresistance threshold value may be set to a value less than 1 Mega-Ohms,such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. Thisis indicative of a saturation of the first electrode pair by themoisture detected and there are no further changes expected by the firstprimary parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterionmay be determined(P_2_1<TH_low),wherein P_2_1 is a second primary parameter based on the secondparameter data, TH_low is a threshold value corresponding to a lowerresistance threshold value. In one or more exemplary embodiments, alower resistance threshold value may be set to a value less than 1Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79kilo-Ohms. This is indicative of a saturation of the second electrodepair by the moisture detected and there are no further changes expectedby the second primary parameter. Moisture is likely to continue itsprogression.

In one or more exemplary embodiments, the following additional criterionmay be determined:(P_3_1>TH_low),

P_3_1 is a third primary parameter based on the third parameter data,and TH_low is a threshold value corresponding to a lower resistancethreshold value. In one or more exemplary embodiments, a lowerresistance threshold value may be set to a value less than 1 Mega-Ohms,such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. Thisis indicative of a saturation of the third electrode pair by themoisture detected and there are no further changes expected by thesecond primary parameter. Moisture is likely to continue itsprogression.

In one or more exemplary embodiments, one or more criteria of a criteriaset, e.g. one or more first criteria of the first criteria set and/orone or more second criteria of the second criteria set, may be based ontiming information or one or more delay parameters based on theparameter data. In one or more exemplary embodiments, one or more delayparameters or time differences related to different parameter data, e.g.related to the first parameter data and the second parameter data, aredetermined.

In one or more exemplary embodiments, one or more first criteria of thefirst criteria set may be based on timing information (e.g. one or moredelay parameters of the parameter data and/or one or more times where aparameter crosses a threshold).

In one or more exemplary embodiments, the timing information maycomprise a time difference D_1_2_1 between a time T1 where P_1_1 crossesa threshold, such as TH_1_1, and a time T2 where P_2_1 crosses athreshold, such as TH_1_2. Thus, delay parameter or time differenceD_1_2_1 may be given as D_1_2_1=T2−T1.

In one or more exemplary embodiments, the timing information, e.g. usedin the first criteria set, may comprise a time difference D_2_3_1between a time T2 where P_2_1 crosses a threshold, such as TH_1_2, and atime T3 where P_3_1 crosses a threshold, such as TH_1_3. Thus, delayparameter or time difference D_2_3_1 may be given as D_2_3_1=T3−T2.

In one or more exemplary embodiments, one or more criteria sets, such asthe third criteria set and/or the second criteria set, may comprise anyof:D_1_2_1>ZD_2_3_1>Z

Wherein Z is a time difference constant characterizing the progressionof moisture (e.g. 3 h, e.g. 2 h). Different time difference constantsmay be employed in different criteria sets/for different time delays.

In one or more exemplary embodiments, one or more criteria sets, such asthe second criteria set and/or the third criteria set may comprise anyof:D_1_2_1>Z

Wherein Z is a time difference constant characterizing the progressionof moisture (e.g. 3 h, e.g. 2 h).

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate. The second parameter data maycomprise a second secondary parameter, and/or a second tertiaryparameter, which may be derived from the second primary parameter. Asecond secondary parameter may be indicative of a voltage between thesecond electrode pair (second electrode and second electrode part of theground electrode) of the base plate.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate. The third parameter data maycomprise a third secondary parameter, and/or a third tertiary parameter,which may be derived from the third primary parameter. A third secondaryparameter may be indicative of a voltage between the second electrodepair (second electrode and second electrode part of the groundelectrode) of the base plate.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second criteria set based on thesecond parameter data and/or the third parameter data, wherein theoperating state is determined to be the second operating state if thesecond criteria set is satisfied. The second criteria set may be basedon the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second threshold set comprisingone or a plurality of second threshold values. The second threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the second criteria set. The second threshold set may comprise asecond primary threshold value. The second threshold set may comprise asecond secondary threshold value. The second threshold set may comprisea second tertiary threshold value.

The second criteria set may be given by or at least may comprise(P_1_1<TH_2_1),(P_2_1<TH_2_2), and(P_3_1>TH_2_3)wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_2_1 is a second primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_2_2 is a secondsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_2_3 is a second tertiary threshold value, andwherein the second operating state is indicative of medium degree ofradial erosion or radial swelling on the base plate. The secondthreshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate. The second primary criterion (P_1_1<TH_2_1) and/or the secondtertiary criterion (P_3_1>TH_2_3) may be omitted in the second criteriaset.

The second operating state indicative of medium degree of radial erosionon the base plate may be indicative of a radial progression of moistureto the first electrode pair and the second electrode pair (and not thethird electrode pair). The second operating state indicative of mediumdegree of radial erosion on the base plate may be indicative of a radialprogression of moisture to the first electrode pair and to the secondelectrode pair.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the secondthreshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to secondresistance threshold values. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplaryembodiments, the second secondary threshold value TH_2_2 may correspondto the upper resistance threshold. In one or more exemplary embodiments,the second tertiary threshold value TH_2_3 may correspond to the upperresistance threshold value. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to a mediumresistance threshold value. A medium resistance threshold value may beset to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the secondthreshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to secondvoltage threshold values. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to an upper voltagethreshold value. An upper voltage threshold value may be set to a valueless than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or moreexemplary embodiments, the second secondary threshold value TH_2_2 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the second tertiary threshold value TH_2_3 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the second primary threshold value TH_2_1 maycorrespond to a medium voltage threshold value. A medium resistancethreshold value may be set to a value less than 10 Mega-Ohms, such as 5Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1Mega-Ohms.

In one or more exemplary embodiments, the second criteria set maycomprise any of:D_1_2_1>Z

Wherein Z is a time difference constant characterizing the progressionof moisture (e.g. 3 h, e.g. 2 h).

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a default criteria set based on thefirst parameter data, wherein the operating state is determined to bethe default operating state if the default criteria set is satisfied,and in accordance with a determination that the operating state is thedefault operating state, transmit a default monitor signal comprisingmonitor data indicative of the default operating state of the ostomyappliance.

The default criteria set may be given by or at least may comprise(P_1_1>TH_D_1),(P_2_1>TH_D_2), and(P_3_1>TH_D_3)wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_D_1 is a default primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_D_2 is a defaultsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_D_3 is a default tertiary threshold value, andwherein the default operating state is indicative of very low or nodegree of radial erosion or radial swelling on the base plate. Thedefault threshold values (TH_D_1, TH_D_2 and TH_D_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the defaultthreshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to defaultresistance threshold values. In one or more exemplary embodiments, thesecond primary threshold value TH_D_1 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplaryembodiments, the default secondary threshold value TH_D_2 may correspondto the upper resistance threshold. In one or more exemplary embodiments,the default tertiary threshold value TH_D_3 may correspond to the upperresistance threshold value.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the defaultthreshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to defaultvoltage threshold values. In one or more exemplary embodiments, thedefault primary threshold value TH_D_1 may correspond to an uppervoltage threshold value. An upper voltage threshold value may be set toa value less than 5 Volts, such as 3 Volts, such as 2.86 Volts. In oneor more exemplary embodiments, the default secondary threshold valueTH_D_2 may correspond to the upper voltage threshold value. In one ormore exemplary embodiments, the default tertiary threshold value TH_D_3may correspond to the upper voltage threshold value.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a third criteria set based on thethird parameter data, wherein the operating state is determined to bethe third operating state if the third criteria set is satisfied, and inaccordance with a determination that the operating state is the thirdoperating state, transmit a third monitor signal comprising monitor dataindicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a third degree of radial erosionor radial swelling, e.g. the first adhesive layer is eroded or swelledto the third radial distance of the third electrode pair.

The third criteria set may be given by or at least comprise(P_1_1<TH_3_1),(P_2_1<TH_3_2), and(P_3_1<TH_3_3)wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_3_1 is a third primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_3_2 is a thirdsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_3_3 is a third tertiary threshold value, andwherein the third operating state is indicative of high degree of radialerosion or radial swelling on the base plate. The third threshold values(TH_3_1, TH_3_2 and TH_3_3) may be the same or different, e.g. dependingon the electrode configuration of the base plate. The third primarycriterion (P_1_1<TH_3_1) and/or the third secondary criterion(P_2_1<TH_3_2) may be omitted in the third criteria set.

The third operating state indicative of high degree of radial erosion onthe base plate may be indicative of high likelihood of leakage, e.g. onthe proximal side of the base plate, e.g. within a time period e.g.within the next 20 minutes. The third operating state may indicate aradial progression of moisture to the first electrode pair, the secondelectrode pair, and the third electrode pair.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to thirdresistance threshold values. In one or more exemplary embodiments, thethird primary threshold value TH_3_1 may correspond to an upperresistance threshold value. In one or more exemplary embodiments, thethird secondary threshold value TH_3_2 may correspond to an upperresistance threshold value. In one or more exemplary embodiments, thethird tertiary threshold value TH_3_3 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the third primary threshold valueTH_3_1 may correspond to a lower resistance threshold value. In one ormore exemplary embodiments, a lower resistance threshold value may beset to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80kilo-Ohms, such as 79 kilo-Ohms. In one or more exemplary embodiments,the third secondary threshold value TH_3_2 may correspond to a mediumresistance threshold. A medium resistance threshold value may be set toa value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms. In one or moreexemplary embodiments, the third tertiary threshold value TH_3_3 maycorrespond to the upper resistance threshold. An upper resistancethreshold value may be set to a value which is less than 30 Mega-Ohms,such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to thirdvoltage threshold values. In one or more exemplary embodiments, thethird primary threshold value TH_3_1 may correspond to an upper voltagethreshold value. In one or more exemplary embodiments, the thirdsecondary threshold value TH_3_2 may correspond to an upper voltagethreshold value. In one or more exemplary embodiments, the secondtertiary threshold value TH_2_3 may correspond to the upper voltagethreshold value.

In one or more exemplary embodiments, the third primary threshold valueTH_3_1 may correspond to a lower voltage threshold value. In one or moreexemplary embodiments, a lower voltage threshold value may be set to avalue which is less than 1 Volt, such as 0.5 Volt, such as 0.25 Volts,such as 0.22 Volts. In one or more exemplary embodiments, the thirdsecondary threshold value TH_3_2 may correspond to a medium voltagethreshold value. A medium voltage threshold value may be set to a valueless than 2 Volts, such as 1.5 Volts. In one or more exemplaryembodiments, the second tertiary threshold value TH_2_3 may correspondto the upper voltage threshold value.

In one or more exemplary embodiments, the third criteria set maycomprise any of:D_1_2_1<ZD_2_3_1<Z

Wherein Z is a time difference constant characterizing the progressionof moisture (e.g. 3 h, e.g. 2 h), a time difference D_1_2_1 between atime T1 where P_1_1 crosses TH_1_1 and a time T2 where P_2_1 crossesTH_1_2, and a time difference D_2_3_1 between a time T2 where P_2_1crosses TH_1_2 and a time T3 where P_3_1 crosses TH_1_3

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair of the base plate. Toapply a processing scheme may comprise to obtain fourth parameter databased on the fourth ostomy data, and determine an operating state of thebase plate of the ostomy appliance based on the fourth parameter data.The monitor device may be configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate corresponds to a situation, wherein the fourth electrodepair detects fluid, such as output, between the proximal surface offirst adhesive layer and the skin of the user at a fourth radialdistance, and thus there is a high risk of leakage from the ostomyappliance in the fourth operating state.

The fourth criteria set may be given by or at least may comprise(P_4_1<TH_4_4)wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair and TH_4_4 is a fourth quaternary threshold value, andwherein the fourth operating state is indicative of high risk of leakagefrom the ostomy appliance.

In one or more exemplary embodiments, the fourth quaternary thresholdvalue TH_4_4 may correspond to an upper resistance threshold value.

In one or more exemplary monitor devices, a fifth operating state of thebase plate corresponds to a situation, wherein the fourth electrode pairdetects fluid, such as sweat, between the proximal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a no leakage from the ostomy appliance in the fifthoperating state.

The fifth operating state may be determined in accordance with adetermination that one or more fifth criterion of a fifth criteria setare satisfied.

The fifth criteria set may be given by or at least may comprise:(P_4_1<TH_5_1)(P_4_2<TH_5_2)(P_4_3<TH_5_3)(∇P_4_1<V)(∇P_4_2<V) and(∇P_4_3<V)

Wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair, P_4_2 is a fourth secondary parameter indicative of theresistance between the fourth electrode and the fifth electrode, P_4_3is a fourth tertiary parameter based on the fourth parameter data andindicative of the resistance between the fifth electrode pair and TH_5_1is a fifth primary threshold value, TH_5_2 is a fifth secondarythreshold value TH_5_3 is a fifth tertiary threshold value and ∇P_4_1 isgradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is gradient ofP_4_3, and V is a gradient limit (e.g. 80%). In one or more exemplaryembodiments, the fifth primary threshold value TH_5_1 may correspond toan upper resistance threshold value. In one or more exemplaryembodiments, TH_5_2 may correspond to an upper resistance thresholdvalue. In one or more exemplary embodiments, TH_5_3 may correspond to anupper resistance threshold value. An upper resistance threshold valuemay be set to a value which is less than 30 Mega-Ohms, such as 25Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The fifthoperating state may refer to presence of sweat detected by the fourthparameter data indicating moisture detected omnidirectionally from thestomal opening and uniformally.

In one or more exemplary monitor devices, the sixth operating state ofthe base plate corresponds to a situation, wherein the fourth electrodepair detects fluid, such as output, between the proximal surface offirst adhesive layer and the skin of the user at a fourth radialdistance, and thus there is a sudden leakage from the ostomy appliancein the sixth operating state.

A sixth operating state may be determined in accordance with adetermination that one or more sixth criteria of a sixth criteria setare satisfied.

The sixth criteria set may comprise a sixth primary criterion, whereinthe sixth primary criterion may comprise:(P_4_1<TH_6_1) and(∇P_4_1>V)

The sixth criteria set may comprise a sixth secondary criterion, whereinthe sixth secondary criterion may comprise:(P_4_2<TH_6_2) and(∇P_4_2>V)

The sixth criteria set may comprise a sixth tertiary criterion, whereinthe sixth tertiary criterion may comprise:(P_4_3<TH_6_3) and(∇P_4_3>V)

Wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair, P_4_2 is a fourth secondary parameter indicative of theresistance between the fourth electrode and the fifth electrode, P_4_3is a fourth tertiary parameter indicative of the resistance between thefifth electrode pair (fifth electrode and ground electrode) and TH_6_1is a sixth primary threshold value, TH_6_2 is a sixth secondarythreshold value TH_6_3 is a sixth tertiary threshold value, and ∇P_4_1is gradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is gradient ofP_4_3, and V is a gradient limit (e.g. 80%). In one or more exemplaryembodiments, the sixth primary threshold value TH_6_1 may correspond toan upper resistance threshold value. In one or more exemplaryembodiments, TH_6_2 may correspond to an upper resistance thresholdvalue. In one or more exemplary embodiments, TH_6_3 may correspond to anupper resistance threshold value. An upper resistance threshold valuemay be set to a value which is less than 30 Mega-Ohms, such as 25Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The sixthoperating state may refer to presence of output detected by the fourthparameter data indicating a sudden leak, e.g. a developing leak. In oneor more exemplary embodiments, when the time T is below X minutes fromthe placement of the base plate, where X is between 5 to 60 minutes, andwhen any of P_1_1, P_2_1, P_3_1 in average over T are below a defaultthreshold value corresponding to an upper resistance threshold value,this indicates that any of the first electrode pair, the secondelectrode pair, and the third electrode pair is cut (e.g. cut by theuser when preparing the base plate for placement around the stoma). Inone or more exemplary embodiments, when the time T is below X minutesfrom the placement of the base plate, where X is between 5 to 60minutes, and when any of P_4_1, P_4_2, P_4_3 in average over T are belowa default threshold value corresponding to an upper resistance thresholdvalue, this indicates an instant leakage, e.g. presence of output on theproximal side.

In one or more exemplary embodiments, any of the first criteria set, thesecond criteria set, the third criteria set, the fourth criteria set,the default criteria set, the fifth criteria set, the sixth criteria setmay be used to define one or more further criteria sets, and thereby todetermine one or more operating states.

In one or more exemplary embodiments, different criteria sets may beused to determine the same operating state.

In one or more exemplary monitor devices, to apply a processing schemecomprises to obtain common parameter data based on a plurality of thefirst ostomy data, the second ostomy data, and the third ostomy data;and determine the operating state of the base plate of the ostomyappliance based on the common parameter data. The common parameter datamay also be denoted or comprise timing information. For example, as alsodescribed in further detail elsewhere in the present disclosure, one ormore criteria of a criteria set, e.g. one or more first criteria of thefirst criteria set and/or one or more second criteria of the secondcriteria set, may be based on timing information or one or more delayparameters based on the parameter data. In one or more exemplaryembodiments, one or more delay parameters or time differences related todifferent parameter data, e.g. related to the first parameter data andthe second parameter data, are determined.

In one or more exemplary monitor devices, to determine an operatingstate comprises to compare the first parameter data and the secondparameter data, and wherein the operating state is based on thecomparison between the first parameter data and the second parameterdata. For example, the second criteria set may comprise a secondcriterion where the first parameter data and the second parameter dataare compared.

In one or more exemplary monitor devices, to determine an operatingstate comprises to compare different parameter data, such as to comparethe first parameter data and the third parameter data and/or to comparethe second parameter data and the third parameter data, and wherein theoperating state is based on the comparison between the differentparameter data.

The monitor data may be indicative of a condition and/or an operatingstate of the ostomy appliance, e.g. a condition and/or operating stateof the base plate disclosed herein. The condition of the ostomyappliance or of the base plate disclosed herein may refer to a level ofa physical property of at least a part of the ostomy appliance, such asa level of moisture and/or temperature of at least a part of the baseplate, such as a level of a physical property of at least a layer of thebase plate, such as a level of moisture and/or temperature of at least alayer of the base plate, such as a level of a physical property of atleast an adhesive layer of the base plate (e.g. a first adhesive layerproximal to the skin of the user). In one or more exemplary accessorydevices, the interface is configured to obtain the monitor data byobtaining the monitor data indicative of the condition comprising amoisture level of a first adhesive layer of the base plate and/or amoisture level of a proximal side of the first adhesive layer. Themoisture level may be seen as representative of a conductive path in thefirst adhesive layer, such as across the first adhesive layer. Themonitor data comprises e.g. data representative of the measurement ofthe electrical properties of the first adhesive layer. In other words,the condition may be seen as a condition of the first adhesive layer.

A method of monitoring an ostomy appliance comprising a base plate, e.g.with a monitor device as disclosed herein, is provided, the methodcomprising: at a monitor device comprising a processor configured toapply a processing scheme; memory; a first interface connected to theprocessor and the memory; and a second interface connected to theprocessor: collecting ostomy data from the base plate and applying aprocessing scheme. Applying the processing scheme comprises: optionallyobtaining first parameter data based on first ostomy data of the ostomydata; obtaining second parameter data based on second ostomy data of theostomy data; obtaining third parameter data based on third ostomy data;and determining an operating state of the base plate based on one ormore of the first parameter data, the second parameter data and thethird parameter data, wherein the operating state may be indicative of adegree of radial erosion or radial swelling of the base plate and/oracute leakage risk for the ostomy appliance. The method comprises, inaccordance with a determination that the operating state is a firstoperating state, transmitting a first monitor signal comprising monitordata indicative of the first operating state of the base plate via thesecond interface; and in accordance with a determination that theoperating state is a second operating state, transmitting a secondmonitor signal comprising monitor data indicative of the secondoperating state of the base plate via the second interface.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system. The docking station may be configured toelectrically and/or mechanically couple the monitor device to thedocking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4 and an ostomypouch (not shown). Further, the ostomy system 1 comprises a monitordevice 6 and an accessory device 8 (mobile telephone). The monitordevice 6 is connectable to the base plate 4 via respective firstconnectors of the monitor device 6 and base plate 4. The monitor device6 is configured for wireless communication with the accessory device 8.Optionally, the accessory device 8 is configured to communicate with aserver device 10 of the ostomy system 1, e.g. via network 12. The serverdevice 10 may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre. Ostomy data or parameter databased on the ostomy data are obtained from electrodes/sensors of theostomy appliance 2 with the monitor device 6. The monitor device 6processes the ostomy data and/or parameter data based on the ostomy datato determine monitor data that are transmitted to the accessory device8. In the illustrated ostomy system, the accessory device 8 is a mobilephone or smartphone, however the accessory device 8 may be embodied asanother handheld device, such as a tablet device, or a wearable, such asa watch or other wrist-worn electronic device. Accordingly, the monitordevice 6 is configured to determine and transmit monitor data to theaccessory device 8. The base plate 4 comprises a coupling member 14 inthe form of a coupling ring 16 for coupling an ostomy pouch (not shown)to the base plate (two-part ostomy appliance). The base plate 4 has astomal opening 18 with a center point 19. The size and/or shape of thestomal opening 18 is typically adjusted by the user or nurse beforeapplication of the ostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming anaccessory device of the ostomy system 1. The docking station comprises20 comprises a docking monitor interface including a first connector 22configured for electrically and/or mechanically connecting the monitordevice 6 to the docking station 20. The docking monitor interface may beconfigured for wirelessly connecting the monitor device to the dockingstation. The docking station 20 comprises a user interface 24 forreceiving user input and/or providing feedback to the user on theoperational state of the docking station 20. The user interface 24 maycomprise a touch-screen. The user interface 24 may comprise one or morephysical buttons and/or one or more visual indicators, such as lightemitting diodes.

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor101, and one or more interfaces, the one or more interfaces including afirst interface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 comprises a ground terminal 108, a first terminal110, a second terminal 112 and a third terminal 114. The first interface102 optionally comprises a fourth terminal 116 and a fifth terminal 118.The first interface 102 of the monitor device 6 comprises a couplingpart 120 for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate. The couplingpart 120 and the terminals 108, 110, 112, 114, 116, and 118 of the firstinterface 102 form (at least part of) a first connector of the monitordevice 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 optionally comprises a sensor unit 140 connected tothe processor 101. The sensor unit 140 comprises a temperature sensorfor feeding temperature data to the processor and/or a G-sensor oraccelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate coupled to the first interface, the ostomy data comprisingfirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. The ostomydata may be stored in the memory 106 and/or processed in the processor101 in order to obtain parameter data. The processor 101 is configuredto apply a processing scheme, wherein to apply a processing schemecomprises obtain first parameter data based on the first ostomy data;obtain second parameter data based on the second ostomy data; obtainthird parameter data based on the third ostomy data. In other words, theprocessor 101 is configured to obtain first, second and third parameterdata based on respective first, second and third ostomy data. To apply aprocessing scheme comprises to determine an operating state of the baseplate of the ostomy appliance based on one or more, e.g. all, of thefirst parameter data, the second parameter data and the third parameterdata, wherein the operating state is indicative of a degree of radialerosion or radial swelling of the base plate and/or acute leakage riskfor the ostomy appliance. The monitor device 6 is configured to, inaccordance with a determination that the operating state is a firstoperating state, transmit a first monitor signal comprising monitor dataindicative of the first operating state of the base plate via the secondinterface; and in accordance with a determination that the operatingstate is a second operating state, transmit a second monitor signalcomprising monitor data indicative of the second operating state of thebase plate via the second interface.

The monitor device 100 is configured to obtain ostomy data from the baseplate coupled to the first interface 102. The ostomy data may be storedin the memory 106 and/or processed in the processor 101 in order toobtain parameter data based on the ostomy data.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200with a stomal opening 18A. During use, a proximal surface of the firstadhesive layer 200 adheres to the user's skin in the peristomal areaand/or to additional seals, such as sealing paste, sealing tape and/orsealing ring. The base plate 4 optionally comprises a second adhesivelayer 202 with a stomal opening 18B. The base plate 4 comprises aplurality of electrodes arranged in an electrode assembly 204. Theelectrode assembly 204 is arranged between the first adhesive layer 200and the second adhesive layer 202. The electrode assembly 204 comprisesa support layer with stomal opening 18C and electrodes formed on aproximal surface of the support layer. The base plate 4 comprises arelease liner 206 that is peeled off by the user prior to applying thebase plate 4 on the skin. The base plate 4 comprises a top layer 208with a stomal opening 18D and a coupling ring 209 for coupling an ostomypouch to the base plate 4. The top layer 208 is a protective layerprotecting the second adhesive layer 202 from external strains andstress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the distalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate. The electrode assembly 204 has a distal side 204Aand a proximal side 204B. The electrode assembly 204 comprises a supportlayer 214 with proximal surface 214B and electrodes 216 arranged on theproximal side of the support layer 214 and including a ground electrode,a first electrode, a second electrode, a third electrode, a fourthelectrode, and a fifth electrode, wherein each electrode has arespective connection part 217 for connecting the electrodes 216 torespective terminal elements of the monitor interface. The electrodes216 are positioned and/or formed on a proximal side 214B of the supportlayer 214. Further, electrode assembly 204 comprises a masking element218 with proximal surface 218B and configured to insulate electrodeparts of electrodes 216 from the first adhesive layer of the base plate.The masking element 218 covers or overlap with parts of the electrodes216 when seen in the axial direction.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate without the first adhesive layer and the release liner.The base plate 4 comprises a first intermediate element 213 on thedistal side of the electrode assembly, i.e. between the electrodeassembly 204 and the first adhesive layer (not shown). The firstintermediate element 213 covers the terminal elements of the base plate4 when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrodeconfiguration 220/electrode assembly 204 comprises a ground electrode222, a first electrode 224, a second electrode 226, a third electrode228, a fourth electrode 230, and a fifth electrode 232. The groundelectrode 222 comprises a ground connection part 222A and the firstelectrode 224 comprises a first connection part 224A. The secondelectrode 226 comprises a second connection part 226A and the thirdelectrode 228 comprises a third connection part 228A. The fourthelectrode 230 comprises a fourth connection part 230A and the fifthelectrode 232 comprise a fifth connection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifthelectrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 234 forforming a ground or reference for the first electrode 224. The groundelectrode 222 comprises a second electrode part 236 for forming a groundor reference for the second electrode 226. The ground electrode 222comprises a third electrode part 238 for forming a ground or referencefor the third electrode 228. The masking element 218 is arrangedproximal to the electrodes 222, 224, 226, 228 covering and insulatingparts of the electrodes from the first adhesive and forming respectiveconductor parts of the electrodes 222, 224, 226, 228. The parts of theelectrodes 222, 224, 226, 228 not covered by the masking element 219contacts the first adhesive layer and form sensing parts 224B, 226B,228B of electrodes 224, 226, 228, respectively. Further, the electrodeparts 234, 236, 238 form sensing parts of the ground electrode 222.

The first sensing part 224B extends circularly at least 330 degreesaround the stomal opening at a first radial distance R1 from the centerpoint 19. The first radial distance R1 is 14 mm. The first electrodepart 234 is arranged on the inside of the first sensing part (i.e.closer to the center point) and extends circularly at least 330 degreesaround the stomal opening at a first ground distance RG1 from the firstsensing part (radially from the center point). The first ground distanceRG1 between sensing part of first electrode and first electrode part isabout 1 mm.

The second sensing part 226B extends circularly at least 330 degreesaround the stomal opening at a second radial distance R2 from the centerpoint 19. The second radial distance R2 is 18 mm. The second electrodepart 236 is arranged on the inside of the second sensing part 226B (i.e.closer to the center point) and extends circularly at least 330 degreesaround the stomal opening at a second ground distance RG2 from thesecond sensing part 226B (radially from the center point). The secondground distance RG2 between sensing part of second electrode and secondelectrode part is about 1 mm.

The third sensing part 228B extends circularly at least 330 degreesaround the stomal opening at a third radial distance R3 from the centerpoint 19. The third radial distance R3 is about 26 mm. The thirdelectrode part 238 is arranged on the inside of the third sensing part228B (i.e. closer to the center point) and extends circularly at least330 degrees around the stomal opening at a third ground distance RG3from the third sensing part 228B (radially from the center point). Thethird ground distance RG3 between sensing part of third electrode andthird electrode part is about 1 mm.

The ground electrode 222 comprises a fourth electrode part 240 forforming a ground or reference for the fourth electrode 230 and the fifthelectrode 232. The fourth electrode part 240 of the ground electrode 222extends at least 300 degrees around the stomal opening and comprisesground sensing parts 222B. The fourth sensing parts 230B, fifth sensingparts 232B, and ground sensing parts of the fourth electrode part 240are circularly distributed around the center point 19 at a leakageradius from the center point. The fourth sensing parts 230B, fifthsensing parts 232B, and ground sensing parts of the fourth electrodepart may have a radial extension larger than 1.0 mm, such as in therange from 1.5 mm to 3.0 mm, e.g. about 2.0 mm. The fourth sensing parts230B, fifth sensing parts 232B, and ground sensing parts of the fourthelectrode part 240 may have a circumferential extension (perpendicularto the radial extension) larger than 1.0 mm, such as in the range from2.5 mm to 5.0 mm, e.g. about 3.5 mm.

FIG. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings includingsix terminal openings. The plurality of terminal openings comprises aground terminal opening 242, a first terminal opening 244, a secondterminal opening 246, a third terminal opening 248, a fourth terminalopening 250, and a fifth terminal opening 252. The terminal openings242, 244, 246, 248, 250, 252 of the masking element 218 are configuredto overlap and/or be aligned with respective connection parts 222A,224A, 226A, 228A, 230A, 232A of the electrodes of the electrodeassembly.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254, each primary sensor point opening configured tooverlap a part of the ground electrode 222 and/or a part of the fourthelectrode 230. The primary sensor point openings 254 comprise, in theillustrated exemplary masking element, five primary first sensor pointopenings 254A each configured to overlap a part of the ground electrode222. The primary sensor point openings 254 comprise, in the illustratedexemplary masking element, four primary second sensor point openings254B each configured to overlap a part of the fourth electrode 230. Thesensor point openings comprise secondary sensor point openings shownwithin dotted line 256, each second sensor point opening configured tooverlap a part of the fourth electrode 230 and/or a part of the fifthelectrode 232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, five secondary first sensor pointopenings 256A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, four secondary second sensorpoint openings 256B each configured to overlap a part of the fourthelectrode 230. The sensor point openings comprise tertiary sensor pointopenings shown within dotted line 258, each tertiary sensor openingconfigured to overlap a part of the fifth electrode 232 and/or a part ofthe ground electrode 222. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, five tertiaryfirst sensor point openings 258A each configured to overlap a part ofthe fifth electrode 232. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, four tertiarysecond sensor point openings 258B each configured to overlap a part ofthe ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor point openings. The sensorpoint openings of the first adhesive layer comprise primary sensor pointopenings shown within dotted line 260, each primary sensor point openingconfigured to overlap a part of the ground electrode 222 and/or a partof the fourth electrode 230 of the electrode assembly. The primarysensor point openings comprise, in the illustrated exemplary firstadhesive layer, five primary first sensor point openings 260A eachconfigured to overlap a part of the ground electrode 222. The primarysensor point openings comprise, in the illustrated exemplary firstadhesive layer, four primary second sensor point openings 260B eachconfigured to overlap a part of the fourth electrode 230. The sensorpoint openings of the first adhesive layer comprise secondary sensorpoint openings shown within dotted line 262, each second sensor pointopening configured to overlap a part of the fourth electrode 230 and/ora part of the fifth electrode 232 of the electrode assembly. Thesecondary sensor point openings comprise, in the illustrated exemplaryfirst adhesive layer, five secondary first sensor point openings 262Aeach configured to overlap a part of the fifth electrode 232. Thesecondary sensor point openings comprise, in the illustrated exemplaryfirst adhesive layer, four secondary second sensor point openings 262Beach configured to overlap a part of the fourth electrode 230. Thesensor point openings of the first adhesive layer comprise tertiarysensor point openings shown within dotted line 264, each tertiary sensoropening configured to overlap a part of the fifth electrode 232 and/or apart of the ground electrode 222 of the electrode assembly. The tertiarysensor point openings comprise, in the illustrated exemplary firstadhesive layer, five tertiary first sensor point openings 264A eachconfigured to overlap a part of the fifth electrode 232. The tertiarysensor point openings comprise, in the illustrated exemplary firstadhesive layer, four tertiary second sensor point openings 264B eachconfigured to overlap a part of the ground electrode 222. FIG. 9 is aproximal view of the first adhesive layer of FIG. 8 .

FIG. 10 is a more detailed distal view of a part of the base plate 4.Monitor interface of the base plate comprises the first connector 211.The first connector 211 comprises coupling part 210 configured toreleasably couple the monitor device to the base plate and thus forminga releasable coupling. The first connector 211/monitor interfacecomprises a plurality of terminals formed by respective terminalelements for forming respective electrical connections with respectiveterminals of the monitor device.

The plurality of terminals of the first connector 211/monitor interfacecomprises a ground terminal element 282 forming a ground terminal 282A,a first terminal element 284 forming a first terminal 284, a secondterminal element 286 forming a second terminal 286A, and optionally athird terminal element 288 forming a third terminal 288A. The monitorinterface optionally comprises a fourth terminal element 290 forming afourth terminal 290A and/or a fifth terminal element 292 forming a fifthterminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contactrespective connection parts 222A, 224A, 226A, 228A, 230 a, 232A ofelectrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate, the number ofterminals and the position of the terminals in the coupling part may beadapted to the electrode configuration used in the electrode assembly ofthe base plate.

FIG. 11 is an exemplary graphical presentation of primary parametersbeing the resistance between respective electrode pairs of base plate 4as a function of time during use of the base plate. At time t<t_1, thebase plate is in a default state. At time t=t_1, the first primaryparameter P_1_1 (resistance between first electrode and ground electrode(first electrode part)) drops below a first primary threshold valueTH_1_1 to fulfil a first criterion set, and the monitor devicedetermines that the base plate is now in a first operating state. Attime t=t_2, the second primary parameter P_2_1 (resistance betweensecond electrode and ground electrode (second electrode part)) dropsbelow a second secondary threshold value TH_2_2 to fulfil a secondcriterion set, and the monitor device determines that the base plate isnow in a second operating state. At time t=t_3, the third primaryparameter P_3_1 (resistance between third electrode and ground electrode(third electrode part)) drops below a third tertiary threshold valueTH_3_3 to fulfil a third criteria set, and the monitor device determinesthat the base plate is now in a third operating state. At time t=t_4,the fourth primary parameter P_4_1 (e.g. resistance between fourthelectrode and ground electrode (first electrode part) drops below afourth quaternary threshold value TH_4_4 to fulfil a fourth criteriaset, and the monitor device determines that the base plate is now in afourth operating state (high risk of leakage from the ostomy appliancebetween the skin and the first adhesive layer).

FIG. 12 is a flow diagram of a method of monitoring an ostomy appliancecomprising a base plate. The method 1000 comprises, at a monitor devicecomprising a processor configured to apply a processing scheme; memory;a first interface connected to the processor and the memory; and asecond interface connected to the processor: collecting 1002 ostomy datafrom the base plate and applying a processing scheme. Applying aprocessing scheme comprises obtaining 1004 first parameter data based onfirst ostomy data of the ostomy data; obtaining 1006 second parameterdata based on second ostomy data of the ostomy data; obtaining 1008third parameter data based on third ostomy data; optionally obtaining1010 fourth parameter data based on fourth ostomy data; and determining1011 an operating state of the base plate based on the first parameterdata, the second parameter data and the third parameter data, whereinthe operating state is indicative of a degree of radial erosion orradial swelling of the base plate and/or acute leakage risk for theostomy appliance. Determining 1011 an operating state of the base platemay be based on the fourth parameter data. The method 1000 comprises, inaccordance 1012 with a determination that the operating state is a firstoperating state, transmitting 1014 a first monitor signal comprisingmonitor data indicative of the first operating state of the base platevia the second interface; and in accordance 1016 with a determinationthat the operating state is a second operating state, transmitting 1018a second monitor signal comprising monitor data indicative of the secondoperating state of the base plate via the second interface.

FIG. 13 is a flow diagram of a method of monitoring an ostomy appliancecomprising a base plate. The method 1000A comprises, at a monitor devicecomprising a processor configured to apply a processing scheme; memory;a first interface connected to the processor and the memory; and asecond interface connected to the processor: collecting 1002 ostomy datafrom the base plate and applying a processing scheme. Applying aprocessing scheme comprises obtaining 1004 first parameter data based onfirst ostomy data of the ostomy data; obtaining 1006 second parameterdata based on second ostomy data of the ostomy data; obtaining 1008third parameter data based on third ostomy data; and optionallyobtaining 1010 fourth parameter data based on fourth ostomy data. Themethod 1000A comprises determining 1020 if a change criterion isfulfilled and, in accordance with the change criterion being satisfied,determining 1011 an operating state of the base plate based on the firstparameter data, the second parameter data and the third parameter data,wherein the operating state is indicative of a degree of radial erosionor radial swelling of the base plate and/or acute leakage risk for theostomy appliance.

Determining 1011 an operating state of the base plate may be based onthe fourth parameter data. In accordance 1012 with a determination thatthe operating state is a first operating state, the method 1000Acomprises transmitting 1014 a first monitor signal comprising monitordata indicative of the first operating state of the base plate via thesecond interface; and in accordance 1016 with a determination that theoperating state is a second operating state, transmitting 1018 a secondmonitor signal comprising monitor data indicative of the secondoperating state of the base plate via the second interface. Inaccordance with the change criterion not being satisfied, the method1000A returns to collecting ostomy data 1002. Thus, operating statedetermination 1011 may be conditional or dependent on a change in theparameter data, in turn leading to an optimum use of power or batteryresources in the monitor device, since operating state determination isonly performed when there may be a change in the operating state as aconsequence of the change in parameter data.

FIG. 14 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1100 shows, as a function oftime, first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1102 shows, as a function oftime, second parameter data indicative of voltage measured by the secondelectrode pair of the base plate. Curve 1104 shows, as a function oftime, third parameter data indicative of voltage measured by the thirdelectrode pair of the base plate. Curves 1108, 1116, 1118 show, as afunction of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate, and fourth tertiaryparameter indicative of voltage measured by the fifth electrode pair ofthe base plate respectively. Curves 1110, 1112, 1114 show, as a functionof time, a gradient of fourth primary parameter indicative of voltagegradient measured by the fourth electrode pair of the base plate, agradient of fourth secondary parameter indicative of voltage gradientmeasured by the fourth electrode and the fifth electrode of the baseplate (sixth electrode pair), and a gradient of fourth tertiaryparameter indicative of voltage gradient measured by the fifth electrodepair of the base plate respectively. FIG. 14 shows the upper voltagethreshold value represented as curve 1050, the medium voltage thresholdvalue represented as curve 1052, the lower voltage threshold valuerepresented as curve 1054, and curve 1056 is a gradient limit.

Curves 1108, 1116, 1118 as well as curves 1110, 1112, 1114 show that nomoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair.

At a time less than 5 h, curve 1100 shows that moisture is detected bythe first electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1102 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time between 5 h and 10 h, curve 1102 shows that moisture is detectedby the second electrode pair as the second parameter data crosses theupper voltage threshold value. At this stage, it is determined that theostomy appliance is in a second operating state.

At time around 45 h, curve 1104 shows that moisture is detected by thethird electrode pair as the third parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a third operating state.

FIG. 15 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1202 shows, as a function oftime, first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1204 shows, as a function oftime, second parameter data indicative of voltage measured by the secondelectrode pair of the base plate. Curve 1200 shows, as a function oftime, third parameter data indicative of voltage measured by the thirdelectrode pair of the base plate. Curves 1206, 1208, 1210 show, as afunction of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate (sixth electrodepair), and fourth tertiary parameter indicative of voltage measured bythe fifth electrode pair of the base plate respectively. Curves 1212,1214, 1216 show, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient measured by the fourthelectrode pair of the base plate, a gradient of fourth secondaryparameter indicative of voltage gradient measured by the fourthelectrode and the fifth electrode of the base plate, and a gradient offourth tertiary parameter indicative of voltage gradient measured by thefifth electrode pair of the base plate respectively. FIG. 15 shows theupper voltage threshold value represented as curve 1050, the mediumvoltage threshold value represented as curve 1052, the lower voltagethreshold value represented as curve 1054, and curve 1056 represents agradient limit.

Curves 1206, 1208, 1210 as well as curves 1212, 1214, 1216 show thatmoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair, the fourth and fifth electrode, and the fifthelectrode pair at a time starting at 60 h until 90 h. As the threeelectrode pairs are triggered as shown by the decreases shown by 1206,1208, 1210 and as the curves 1212, 1214, 1216 show a gradient below 80%,this is indicative of the presence of sweat at the proximal side of thefirst adhesive layer.

At a time of 30 min, curve 1202 shows that moisture is detected by thefirst electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1204 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time around 40 h, curve 1204 shows that moisture is detected by thesecond electrode pair as the second parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a second operating state.

FIG. 16 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1300 shows, as a function oftime, first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1302 shows, as a function oftime, second parameter data indicative of voltage measured by the secondelectrode pair of the base plate. Curve 1304 shows, as a function oftime, third parameter data indicative of voltage measured by the thirdelectrode pair of the base plate. Curves 1306, 1308, 1310 show, as afunction of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate, and fourth tertiaryparameter indicative of voltage measured by the fifth electrode pair ofthe base plate respectively. Curves 1312, 1314, 1316 show, as a functionof time, a gradient of fourth primary parameter indicative of voltagegradient measured by the fourth electrode pair of the base plate, agradient of fourth secondary parameter indicative of voltage gradientmeasured by the fourth electrode and the fifth electrode of the baseplate, and a gradient of fourth tertiary parameter indicative of voltagegradient measured by the fifth electrode pair of the base platerespectively. FIG. 16 shows the upper voltage threshold valuerepresented as curve 1050, the medium voltage threshold valuerepresented as curve 1052, the lower voltage threshold value representedas curve 1054, and curve 1056 is a gradient limit.

Curves 1306, 1308, 1310 as well as curves 1312, 1314, 1316 show thatmoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair at a time starting at around 25 h. As leakageelectrodes (i.e. the fourth electrode pair, the fourth and fifthelectrode, and the fifth electrode pair) are trigger as shown by thedecreases shown by 1306, 1308, 1310 and as curve 1312, 1314, 1316 show agradient above 80%, this is indicative of the presence of output at theproximal side of the first adhesive layer. This indicate severe leakage.It may be determined that the ostomy appliance is in a sixth operatingstate.

At a time of 5 h, curve 1300 shows that moisture is detected by thefirst electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1302 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time around 15 h, curve 1302 shows that moisture is detected by thesecond electrode pair as the second parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a second operating state.

At time around 30 h, curve 1304 shows that moisture is detected by thethird electrode pair as the third parameter data crosses the uppervoltage threshold value. In an example where the curves 1306, 1308, 1310had not dropped below corresponding thresholds, curve 1304 indicatesthat moisture has reached the third electrode pair, and the presentdisclosure enables determining that the ostomy appliance is in a thirdoperating state.

FIG. 17 shows an exemplary graphical representation of parameter data asa function of time and a whitening zone diameter (e.g. related to aradial thickness of a whitening ring surrounding the stomal opening) asa function of time. FIG. 17 illustrates the moisture propagation in thefirst adhesive layer as a function of time, and illustrates acorrelation between parameter data detected by the first electrode pairand the second electrode pair of the base plate and actual moisture onthe proximal surface of the first adhesive layer of the base plate. Theactual moisture propagation in the first adhesive layer may appear as awhitening zone (e.g. a white ring around the stomal opening) in thefirst adhesive layer. Moisture affects the first adhesive layer in thatthe moisture reacts with the composition of the first adhesive layer toform the white ring around the stomal opening, and thereby reducesadhesive performance of the base plate. FIG. 17 is obtained byexperiments where water is applied from the stomal opening of the basedplate to follow, using the electrodes of the base plate, the radialpropagation of moisture leading to radial erosion of the first adhesivelayer of the base plate.

Curve 1502 shows, as a function of time, first parameter data indicativeof voltage measured by the first electrode pair of the base plate. Curve1504 shows, as a function of time, second parameter data indicative ofvoltage measured by the second electrode pair of the base plate. Curve1506 shows a diameter of the white ring as a function of time. The firstparameter data shows a decrease in e.g. voltage measured by the firstelectrode pair over time. It is also seen that the voltage of the secondelectrode pair drops at a later time than when the first parameter datashows a decrease in e.g. voltage dropped. This correlates well with thediameter of the white ring which goes from around 25-26 mm when thefirst electrode pair is triggered (e.g. first parameter data shows adecrease) to 38 mm when the second electrode pair is triggered (secondparameter data shows a decrease). This corresponds substantially to thelocation of the first electrode pair at twice the first radial distanceR1, and of the second electrode pair at twice the second radial distanceR2.

It is noted that various regions and countries have various routines andrecommendations to support optimal use of an ostomy appliance. Forexample, in regions of Europe, it may be indicated to the user that anostomy appliance with a base plate as disclosed herein is an optimalstate (corresponding to a first operating state) when the radialthickness of the whitening ring is between 0-15 mm (for a user not incompliance with a preferred use), such as between 0-7 mm (for a user incompliance with a preferred use), such as between 0-5 mm (recommended bya nurse).

For example, in Europe, it may be indicated to the user that an ostomyappliance with a base plate as disclosed herein is in suboptimal state(corresponding to a second operating state) and thereby indicate aconsideration to change the base plate when the radial thickness of thewhitening ring is such as between 5-10 mm (recommended by a nurse),between 7 mm and 10 mm (for a user in compliance with a preferred use),and/or between 15 mm and 30 mm (for a user not in compliance with apreferred use).

For example, in Europe, it may be indicated to the user that an ostomyappliance with a base plate as disclosed herein is in a poor state(corresponding to a third operating state) and indicate a request tochange the base plate when the radial thickness of the whitening ring ismore than 10 mm (recommended by a nurse), such as more than 15 mm (for auser in compliance with a preferred use), such as more than 30 mm (for auser not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isan optimal state (corresponding to a first operating state) when theradial thickness of the whitening ring is between 0-20 mm (for a usernot in compliance with a preferred use), such as between 0-10 mm (for auser in compliance with a preferred use), such as between 0-10 mm(recommended by a nurse).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isin suboptimal state (corresponding to a second operating state) andthereby indicate a consideration to change the base plate when theradial thickness of the whitening ring is such as between 10 mm and 20mm (recommended by a nurse), between 10 mm and 20 (for a user incompliance with a preferred use), and/or between 20 mm and 40 mm (for auser not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isin a poor state (corresponding to a third operating state) and indicatea request to change the base plate when the radial thickness of thewhitening ring is more than 20 mm (recommended by a nurse), such as morethan 20 mm (for a user in compliance with a preferred use), such as morethan 40 mm (for a user not in compliance with a preferred use).

The disclosed methods, ostomy appliances, monitor devices, and accessorydevices allow to accommodate the regional preferences of user in theiruse of the ostomy appliance so as to adjust thresholds for the operatingstates to the regional preference or use.

FIGS. 18A-18B shows exemplary graphical representations of peel force asa function of a peeling distance travelled by a peeling actionexercising the peel force (e.g. perpendicularly to the proximal (ordistal) surface of the first adhesive layer) on a first adhesive layerof a base plate disclosed herein. The peel force relates to a requiredforce to peel the first adhesive layer off the skin surface. The peelingdistance is with respect to one end of the first adhesive layer wherethe peel force starts to be exercised. The peeling distance relates tothe size or length of the first adhesive layer and thereby may relate toa size or length of a portion the first adhesive layer affected bymoisture and of a portion of the first adhesive layer not affected bymoisture. The peel forces illustrated in FIGS. 18A-18B arerepresentative of adhesive performance of the first adhesive layer ofthe base plate to the skin surface.

Composition of the first adhesive layer of the base plate as disclosedherein in one or more embodiments is formulated to provide adhesion ofthe base plate to the skin surface of the user when the base plate isworn and to maintain a dry and healthy skin surface. Avoiding macerationof skin when occluding the skin with an adhesive is done by transportingsweat away from the skin and into the first adhesive layer by means ofe.g. hydrocolloid types and adhesive (e.g. hydrocolloid adhesives)forming part of an absorbing element of the first adhesive layer.

For example, when the absorbing element is in contact with moisture,(e.g. water, sweat, urine or faeces), the absorbing element absorb themoisture. This reduces the adhesion of the first adhesive layer to theskin.

For example, the first adhesive layer goes from a dry adhesive statewith acceptable adhesive performance (e.g. acceptable adhesion andcohesion) in to a wet adhesive state (e.g. reduced or non adhesion andlow cohesion gel).

Curve 1602 of FIGS. 18A and 18B shows a peel force applied to the firstadhesive layer as a function of a peeling distance travelled by apeeling action exercising the peel force on the first adhesive layer ina dry adhesive state, (e.g. not affected by moisture). The peel force isexpressed in Newtons while the peeling distance is expressed in mm. Thelength of the first adhesive layer in dry adhesive state is illustratedby X5, corresponding to length of the first adhesive layer 1608 in dryadhesive state.

Curve 1602 shows that the peel force applied to the first adhesive layerin a dry adhesive state is equal to Y1 when the peeling distance is lessthan X1. At X1, the peeling force drops as the peeling distanceincreases towards X5 and the end of the first adhesive layer.

Curve 1604 of FIG. 18A shows a peel force applied to the first adhesivelayer as a function of a peeling distance travelled by a peeling actionexercising the peel force on the first adhesive layer in a wet adhesivestate, (e.g. affected by moisture to the point of reaching a completelywet adhesive state, where the first adhesive layer has become a gel).

Curve 1604 shows that when the peeling distance is less than X2, thepeel force applied to the first adhesive layer in a wet adhesive stateis equal to Y2 which has much lower value than Y1. This shows that theadhesive performance of the first adhesive layer is reduced when thefirst adhesive layer is in a wet adhesive state. At X2, the peelingforce drops as the peeling distance increases until the end of the firstadhesive layer. It is noted that X2 is larger than X1, because the firstadhesive layer in a wet adhesive state extends in volume, and thus inlength due to the gelling of the components of the first adhesive layer.

The peel experiment illustrated in FIG. 18A shows a loss of adhesiveperformance when the first adhesive is in a wet adhesive state.

Curve 1606 of FIG. 18B shows a peel force applied to the first adhesivelayer as a function of a peeling distance travelled by a peeling actionexercising the peel force on the first adhesive layer illustrated 1610which comprises a first portion 1610A in a dry adhesive state and asecond portion 1610B in a wet adhesive state, (e.g. affected by moistureto the point of reaching a completely wet adhesive state, where thefirst adhesive layer has become a gel).

Curve 1606 shows that when the peeling distance is less than X3, thepeel force applied to the first adhesive layer in a wet adhesive stateis equal to Y3 which has lower value than Y1. This shows that theadhesive performance of the first adhesive layer is reduced when thefirst adhesive layer comprises a portion in a wet adhesive state. At X3,the peeling force drops as the peeling distance increases until the endof the first adhesive layer. It is noted that X3 corresponds to thelength of the portion 1610A in dry adhesive state.

The peel experiment illustrated in FIG. 18B shows a loss of adhesiveperformance when the first adhesive is partly in a wet adhesive state.

Accordingly, FIGS. 18A-18B demonstrate that the operating statedetermined based on monitor data is indicative of adhesive performanceof the base plate.

Also disclosed are monitor devices, ostomy system, and methods accordingto any one of the following items.

Item 1. A monitor device for an ostomy system comprising an ostomyappliance with a base plate, the monitor device comprising:

-   -   a processor configured to apply a processing scheme;    -   memory;    -   a first interface connected to the processor and the memory, the        first interface configured for collecting ostomy data from the        base plate coupled to the first interface; and    -   a second interface connected to the processor,        wherein to apply a processing scheme comprises:    -   obtain parameter data based on the ostomy data; and    -   determine an operating state of the base plate of the ostomy        appliance based on the parameter data,        wherein the monitor device is configured to transmit a monitor        signal comprising monitor data indicative of the determined        operating state of the base plate via the second interface.

Item 2. Monitor device according to item 1, wherein to obtain parameterdata based on the ostomy data comprises to obtain first parameter databased on first ostomy data of the ostomy data from a first electrodepair of the base plate, and wherein to determine the operating state ofthe base plate of the ostomy appliance based on the parameter datacomprises to determine the operating state of the base plate of theostomy appliance based on the first parameter data.

Item 3. Monitor device according to any of items 1-2, wherein to obtainparameter data based on the ostomy data comprises to obtain secondparameter data based on second ostomy data of the ostomy data from asecond electrode pair of the base plate, and wherein to determine theoperating state of the base plate of the ostomy appliance based on theparameter data comprises to determine the operating state of the baseplate of the ostomy appliance based on the second parameter data.

Item 4. Monitor device according to any of items 1-3, wherein to obtainparameter data based on the ostomy data comprises to obtain thirdparameter data based on third ostomy data of the ostomy data from athird electrode pair of the base plate, and wherein to determine theoperating state of the base plate of the ostomy appliance based on theparameter data comprises to determine the operating state of the baseplate of the ostomy appliance based on the third parameter data.

Item 5. Monitor device according to any of items 1-4, wherein theoperating state is indicative of a degree of radial erosion of the baseplate and/or acute leakage risk for the ostomy appliance.

Item 6. Monitor device according to any of items 1-5, wherein theoperating state is indicative of a degree of radial swelling of the baseplate/first adhesive layer and/or is indicative of adhesive performanceof the base plate/first adhesive layer.

Item 7. Monitor device according to any of items 1-6, wherein themonitor device is configured to, in accordance with a determination thatthe operating state is a first operating state, transmit a first monitorsignal comprising monitor data indicative of the first operating stateof the base plate via the second interface.

Item 8. Monitor device according to any of items 1-7, wherein themonitor device is configured to, in accordance with a determination thatthe operating state is a second operating state, transmit a secondmonitor signal comprising monitor data indicative of the secondoperating state of the base plate via the second interface.

Item 9. Monitor device according to any of items 1-8, wherein todetermine an operating state of the base plate is based on a firstcriteria set, e.g. based on the first parameter data and the secondparameter data, wherein the operating state is determined to be thefirst operating state if the first criteria set is satisfied.

Item 10. Monitor device according to any of items 1-9, wherein todetermine an operating state of the base plate is based on a firstthreshold set comprising one or more first threshold values.

Item 11. Monitor device according to any of items 1-10, wherein todetermine an operating state of the base plate is based on a secondcriteria set, e.g. based on the second parameter data and the thirdparameter data, wherein the operating state is determined to be thesecond operating state if the second criteria set is satisfied.

Item 12. Monitor device according to any of items 1-11, wherein todetermine an operating state of the base plate is based on a secondthreshold set comprising one or more second threshold values.

Item 13. Monitor device according to any of items 1-12, wherein todetermine an operating state of the base plate is based on a defaultcriteria set, e.g. based on the first parameter data, wherein theoperating state is determined to be the default operating state if thedefault criteria set is satisfied, and in accordance with adetermination that the operating state is the default operating state,transmit a default monitor signal comprising monitor data indicative ofthe default operating state of the ostomy appliance.

Item 14. Monitor device according to any of items 1-13, wherein todetermine an operating state of the base plate is based on a thirdcriteria set, e.g. based on the third parameter data, wherein theoperating state is determined to be the third operating state if thethird criteria set is satisfied, and in accordance with a determinationthat the operating state is the third operating state, transmit a thirdmonitor signal comprising monitor data indicative of the third operatingstate of the ostomy appliance.

Item 15. Monitor device according to any of items 1-14, wherein thefirst parameter data, the second parameter data, and the third parameterdata are indicative of resistance between the first electrode pair, thesecond electrode pair, and the third electrode pair, respectively.

Item 16. Monitor device according to any of items 1-15, wherein thefirst parameter data, the second parameter data, and the third parameterdata are indicative of a rate of change in resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

Item 17. Monitor device according to any of items 1-16, wherein theostomy data comprises fourth ostomy data from a fourth electrode pair ofthe base plate, and wherein to apply a processing scheme comprises:

-   -   obtain fourth parameter data based on the fourth ostomy data,        and    -   determine an operating state of the base plate of the ostomy        appliance based on the fourth parameter data.

Item 18. Monitor device according to any of items 1-17, wherein themonitor device is configured to, in accordance with a determination thatthe operating state is a fourth operating state, transmit a fourthmonitor signal comprising monitor data indicative of the fourthoperating state of the ostomy appliance.

Item 19. Monitor device according to any of items 1-18, wherein to applya processing scheme comprises:

-   -   obtain common parameter data based on a plurality of the first        ostomy data, the second ostomy data, and the third ostomy data;        and    -   determine the operating state of the base plate of the ostomy        appliance based on the common parameter data.

Item 20. Monitor device according to any of items 1-19 as dependent onitem 9, wherein the first criteria set comprises a first primarycriterion based on the first parameter data, a first secondary criterionbased on the second parameter data, and a first tertiary criterion basedon the third parameter data.

Item 21. Monitor device according to item 20, wherein the first criteriaset is given by(P_1_1<TH_1_1),(P_2_1>TH_1_2), and(P_3_1>TH_1_3),wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_1_1 is a first primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_1_2 is a firstsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of resistance between the thirdelectrode pair, and TH_1_3 is a first tertiary threshold value, andwherein the first operating state is indicative of low degree of radialerosion on the base plate.

Item 22. Monitor device according to any of items 1-21 as dependent onitem 11, wherein the second criteria set comprises a second primarycriterion based on the first parameter data, a second secondarycriterion based on the second parameter data, and a second tertiarycriterion based on the third parameter data.

Item 23. Monitor device according to item 22, wherein the secondcriteria set is given by(P_1_1<TH_2_1),(P_2_1<TH_2_2), and(P_3_1>TH_2_3)wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_2_1 is a second primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_2_2 is a secondsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_2_3 is a second tertiary threshold value, andwherein the second operating state is indicative of medium degree ofradial erosion on the base plate.

Item 24. Monitor device according to any of items 1-23, wherein todetermine an operating state comprises to compare the first parameterdata and the second parameter data, and wherein the operating state isbased on the comparison between the first parameter data and the secondparameter data.

Item 25. Monitor device according to any of items 1-24, wherein thesecond interface comprises a loudspeaker connected to the processor, andwherein the processor is configured to transmit a monitor signal via theloudspeaker.

Item 26. Monitor device according to any of items 1-25, wherein thesecond interface comprises an antenna and a wireless transceiver, andwherein the processor is configured to transmit a monitor signal as awireless monitor signal via the antenna and the wireless transceiver.

Item 27. An ostomy system comprising an ostomy appliance and a monitordevice, the ostomy appliance comprising a base plate, wherein themonitor device is a monitor device according to any of items 1-26.

Item 28. A method of monitoring an ostomy appliance comprising a baseplate, the method comprising:

-   -   at a monitor device comprising a processor configured to apply a        processing scheme; memory; a first interface connected to the        processor and the memory; and a second interface connected to        the processor:    -   collecting ostomy data from the base plate;    -   applying a processing scheme comprising:        -   obtaining parameter data based on the ostomy data; and        -   determining an operating state of the base plate based on            the parameter data,            wherein the method comprises transmitting a monitor signal            comprising monitor data indicative of the determined            operating state of the base plate via the second interface.

Item 29. Method according to item 28, wherein obtaining parameter databased on the ostomy data comprises obtaining first parameter data basedon first ostomy data of the ostomy data.

Item 30. Method according to any of items 28-29, wherein obtainingparameter data based on the ostomy data comprises obtaining secondparameter data based on second ostomy data of the ostomy data.

Item 31. Method according to any of items 28-30, wherein obtainingparameter data based on the ostomy data comprises obtaining thirdparameter data based on third ostomy data of the ostomy data.

Item 32. Method according to any of items 28-31, wherein determining anoperating state of the base plate of the ostomy appliance is based onone or more of the first parameter data, the second parameter data andthe third parameter data.

Item 33. Method according to any of items 28-32, wherein the methodcomprises, in accordance with a determination that the operating stateis a first operating state, transmitting a first monitor signalcomprising monitor data indicative of the first operating state of thebase plate via the second interface.

Item 34. Method according to any of items 28-33, wherein the methodcomprises, in accordance with a determination that the operating stateis a second operating state, transmitting a second monitor signalcomprising monitor data indicative of the second operating state of thebase plate via the second interface.

Item 35. Method according to any of items 28-34, wherein the operatingstate is indicative of a degree of radial erosion of the base plateand/or acute leakage risk for the ostomy appliance.

Item 36. Method according to any of items 28-35, wherein the operatingstate is indicative of a degree of radial swelling of the base plate.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. does not imply any particular order, butare included to identify individual elements. Moreover, the use of theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not denote any order or importance, but rather theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used to distinguish one element from another. Notethat the words “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. are used here and elsewhere for labellingpurposes only and are not intended to denote any specific spatial ortemporal ordering. Furthermore, the labelling of a first element doesnot imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications, and equivalents.

LIST OF REFERENCES

-   1 ostomy system-   2 ostomy appliance-   4 base plate-   6 monitor device-   8 accessory device-   10 server device-   12 network-   14 coupling member-   16 coupling ring-   18, 18A, 18B, 18C, 18D stomal opening-   19 center point-   20 docking station-   22 first connector-   24 user interface-   100 monitor device housing-   101 processor-   102 first interface-   104 second interface-   106 memory-   108 ground terminal of monitor device-   110 first terminal of monitor device-   112 second terminal of monitor device-   114 third terminal of monitor device-   116 fourth terminal of monitor device-   118 fifth terminal of monitor device-   120 coupling part-   121 power unit-   122 antenna-   124 wireless transceiver-   126 loudspeaker-   128 haptic feedback element-   140 sensor unit-   200 first adhesive layer-   200A distal surface of first adhesive layer-   200B proximal surface of first adhesive layer-   202 second adhesive layer-   202A distal surface of second adhesive layer-   202B proximal surface of second adhesive layer-   204 electrode assembly-   204A distal surface of electrode assembly-   204B proximal surface of electrode assembly-   206 release liner-   206A distal surface of the release liner-   206B proximal surface of the release liner-   208 top layer-   208A distal surface of the top layer-   208B proximal surface of the top layer-   209 coupling ring-   210 coupling part of first connector-   211 first connector-   212 terminals of first connector-   213 first intermediate element-   213A distal surface of first intermediate element-   213B proximal surface of first intermediate element-   214 support layer of electrode assembly-   214A distal surface of support layer-   214B proximal surface of support layer-   216 electrodes of electrode assembly-   217 connection parts of electrodes-   218, 219 masking element-   218A distal surface of masking element-   218B proximal surface of masking element-   220, 220A, 220B electrode configuration-   222 ground electrode-   222A ground connection part-   222B ground sensing part-   222C ground connector part-   224 first electrode-   224A first connection part-   224B first sensing part-   224C first conductor part-   226 second electrode-   226A second connection part-   226B second sensing part-   226C second conductor part-   228 third electrode-   228A third connection part-   228B third sensing part-   228C third conductor part-   230 fourth electrode-   230A fourth connection part-   230B fourth sensing part-   232 fifth electrode-   232A fifth connection part-   232B fifth sensing part-   234 first electrode part of the ground electrode-   236 second electrode part of the ground electrode-   238 third electrode part of the ground electrode-   240 fourth electrode part of the ground electrode-   242 ground terminal opening-   244 first terminal opening-   246 second terminal opening-   248 third terminal opening-   250 fourth terminal opening-   252 fifth terminal opening-   254 primary sensor point openings of masking element-   254A primary first sensor point opening-   254B primary second sensor point opening-   256 secondary sensor point openings of masking element-   256A secondary first sensor point opening-   256B secondary second sensor point opening-   258 tertiary sensor point openings of masking element-   258A tertiary first sensor point opening-   258B tertiary second sensor point opening-   260 primary sensor point openings of first adhesive layer-   260A primary first sensor point opening-   260B primary second sensor point opening-   262 secondary sensor point openings of first adhesive layer-   262A secondary first sensor point opening-   262B secondary second sensor point opening-   264 tertiary sensor point openings of first adhesive layer-   264A tertiary first sensor point opening-   264B tertiary second sensor point opening-   282 ground terminal element-   282A ground terminal-   284 first terminal element-   284A first terminal-   286 second terminal element-   286A second terminal-   288 third terminal element-   288A third terminal-   290 fourth terminal element-   290A fourth terminal-   292 fifth terminal element-   292A fifth terminal-   1000, 1000A method of monitoring an ostomy appliance-   1002 collecting ostomy data-   1003 obtaining parameter data-   1004 obtaining first parameter data-   1006 obtaining second parameter data-   1008 obtaining third parameter data-   1010 obtaining fourth parameter data-   1011 determining an operating state-   1012 in accordance with a determination that the operating state is    a first operating state-   1014 transmitting a first monitor signal-   1016 in accordance with a determination that the operating state is    a second operating state-   1018 transmitting a second monitor signal-   1020 determining if change criterion is fulfilled-   1050 curve representing the upper voltage threshold value-   1052 curve representing the medium voltage threshold value-   1054 curve representing the lower voltage threshold value-   1056 curve representing a gradient limit-   1100 curve showing, as a function of time, a first parameter data    indicative of voltage measured by the first electrode pair of the    base plate-   1102 curve showing, as a function of time, a second parameter data    indicative of voltage measured by the second electrode pair of the    base plate-   1104 curve showing, as a function of time, a third parameter data    indicative of voltage measured by the third electrode pair of the    base plate-   1108 curve showing, as a function of time, a fourth primary    parameter indicative of voltage measured by the fourth electrode    pair of the base plate-   1110 curve showing, as a function of time, a gradient of fourth    primary parameter indicative of voltage gradient-   1112 curve showing, as a function of time, a gradient of fourth    secondary parameter indicative of voltage gradient measured-   1114 curve showing, as a function of time, a gradient of fourth    tertiary parameter indicative of voltage gradient measured-   1116 curve showing, as a function of time, a fourth secondary    parameter indicative of voltage measured-   1118 curve showing, as a function of time, a fourth tertiary    parameter indicative of voltage measured-   1200 curve showing, as a function of time, a third parameter data    indicative of voltage measured by the third electrode pair of the    base plate-   1202 curve showing, as a function of time, a first parameter data    indicative of voltage measured by the first electrode pair of the    base plate-   1204 curve showing, as a function of time, a second parameter data    indicative of voltage measured by the second electrode pair of the    base plate-   1206 curve showing, as a function of time, a fourth primary    parameter indicative of voltage measured by the fourth electrode    pair of the base plate-   1208 curve showing, as a function of time, a fourth secondary    parameter indicative of voltage measured-   1210 curve showing, as a function of time, a fourth tertiary    parameter indicative of voltage measured-   1212 curve showing, as a function of time, a gradient of fourth    primary parameter indicative of voltage gradient measured by the    fourth electrode pair of the base plate-   1214 curve showing, as a function of time, a gradient of fourth    secondary parameter data indicative of voltage gradient measured-   1216 curve showing, as a function of time, a gradient of fourth    tertiary parameter indicative of voltage gradient measured-   1300 curve showing, as a function of time, a first parameter data    indicative of voltage measured by the first electrode pair of the    base plate-   1302 curve showing, as a function of time, a second parameter data    indicative of voltage measured by the second electrode pair of the    base plate-   1304 curve showing, as a function of time, a third parameter data    indicative of voltage measured by the third electrode pair of the    base plate-   1306 curve showing, as a function of time, a fourth primary    parameter indicative of voltage measured by the fourth electrode    pair of the base plate-   1308 curve showing, as a function of time, a fourth secondary    parameter indicative of voltage measured-   1310 curve showing, as a function of time, a fourth tertiary    parameter indicative of voltage measured-   1312 curve showing, as a function of time, a gradient of fourth    primary parameter indicative of voltage gradient measured by the    fourth electrode pair of the base plate-   1314 curve showing, as a function of time, a gradient of fourth    secondary parameter indicative of voltage gradient measured-   1316 curve showing, as a function of time, a gradient of fourth    tertiary parameter indicative of voltage gradient measured-   1502 curve showing, as a function of time, a first parameter data    indicative of voltage measured by the first electrode pair of the    base plate-   1504 curve showing, as a function of time, a second parameter data    indicative of voltage measured by the second electrode pair of the    base plate-   1506 curve showing a diameter of the white ring as a function of    time-   1602 curve showing peel force applied to the first adhesive layer in    a dry adhesive state as a function of peeling distance-   1604 a peel force applied to the first adhesive layer as a function    of a peeling distance travelled by a peeling action exercising the    peel force on the first adhesive layer in a wet adhesive state-   1606 a peel force applied to the first adhesive layer as a function    of a peeling distance travelled by a peeling action exercising the    peel force on the first adhesive layer partially wet-   1608 length of the first adhesive layer 1608 in dry adhesive state-   1610 the first adhesive layer which comprises a first portion in a    dry adhesive state and a second portion in a wet adhesive state-   1610A a first portion in a dry adhesive state-   1610B a second portion in a wet adhesive state-   R1 first radial distance-   RG1 first ground distance-   R2 second radial distance-   RG2 second ground distance-   R3 third radial distance-   RG3 third ground distance

The invention claimed is:
 1. A monitor device for a medical systemcomprising a medical appliance with a base plate, the monitor devicecomprising: a processor configured to apply a processing scheme; memory;a first interface connected to the processor and the memory, the firstinterface configured for collecting data from the base plate coupled tothe first interface, the data comprising first data from a firstelectrode pair of the base plate, second data from a second electrodepair of the base plate, and third data from a third electrode pair ofthe base plate; and a second interface connected to the processor,wherein the to apply a processing scheme comprises: obtain firstparameter data based on the first data; obtain second parameter databased on the second data; obtain third parameter data based on the thirddata; and determine an operating state indicative of the dynamicinternal state of the base plate of the appliance based on the firstparameter data, the second parameter data and the third parameter data,wherein the monitor device is configured to, in accordance with adetermination that the operating state is a first operating state,transmit a first monitor signal comprising monitor data indicative ofthe first operating state of the base plate via the second interface;and in accordance with a determination that the operating state is asecond operating state, transmit a second monitor signal comprisingmonitor data indicative of the second operating state of the base platevia the second interface.
 2. The monitor device according to claim 1,wherein the to determine an operating state of the base plate is basedon a first criteria set based on the first parameter data and the secondparameter data, wherein the operating state is determined to be thefirst operating state if the first criteria set is satisfied.
 3. Themonitor device according to claim 1, wherein the to determine anoperating state of the base plate is based on a first threshold setcomprising one or more first threshold values.
 4. The monitor deviceaccording to claim 1, wherein the to determine an operating state of thebase plate is based on a second criteria set based on the secondparameter data and the third parameter data, wherein the operating stateis determined to be the second operating state if the second criteriaset is satisfied.
 5. The monitor device according to claim 1, whereinthe to determine an operating state of the base plate is based on asecond threshold set comprising one or more second threshold values. 6.The monitor device according to claim 1, wherein the to determine anoperating state of the base plate is based on a default criteria setbased on the first parameter data, wherein the operating state isdetermined to be the default operating state if the default criteria setis satisfied, and in accordance with a determination that the operatingstate is the default operating state, transmit a default monitor signalcomprising monitor data indicative of the default operating state of theappliance.
 7. The monitor device according to claim 1, wherein the todetermine an operating state of the base plate is based on a thirdcriteria set based on the third parameter data, wherein the operatingstate is determined to be the third operating state if the thirdcriteria set is satisfied, and in accordance with a determination thatthe operating state is the third operating state, transmit a thirdmonitor signal comprising monitor data indicative of the third operatingstate of the appliance.
 8. The monitor device according to claim 1,wherein the first parameter data, the second parameter data, and thethird parameter data are indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.
 9. The monitor device according to claim 1, wherein thefirst parameter data, the second parameter data, and the third parameterdata are indicative of a rate of change in resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.
 10. The monitor device according to claim 1, wherein thedata comprises fourth data from a fourth electrode pair of the baseplate, and wherein the to apply a processing scheme comprises: obtainfourth parameter data based on the fourth data, and determine anoperating state of the base plate of the appliance based on the fourthparameter data, wherein the monitor device is configured to, inaccordance with a determination that the operating state is a fourthoperating state, transmit a fourth monitor signal comprising monitordata indicative of the fourth operating state of the appliance.
 11. Themonitor device according to claim 1, wherein the to apply a processingscheme comprises: obtain common parameter data based on a plurality ofthe first data, the second data, and the third data; and determine theoperating state of the base plate of the appliance based on the commonparameter data.
 12. The monitor device according to claim 2, wherein thefirst criteria set comprises a first primary criterion based on thefirst parameter data, a first secondary criterion based on the secondparameter data, and a first tertiary criterion based on the thirdparameter data.
 13. The monitor device according to claim 12, whereinthe first criteria set is given by(P_1_1<TH_1_1),(P_2_1>TH_1_2), and(P_3_1>TH_1_3), wherein P_1_1 is a first primary parameter based on thefirst parameter data and indicative of the resistance between the firstelectrode pair, TH_1_1 is a first primary threshold value, P_2_1 is asecond primary parameter based on the second parameter data andindicative of the resistance between the second electrode pair, TH_1_2is a first secondary threshold value, P_3_1 is a third primary parameterbased on the third parameter data and indicative of resistance betweenthe third electrode pair, and TH_1_3 is a first tertiary thresholdvalue, and wherein the first operating state is indicative of low degreeof radial erosion on the base plate.
 14. The monitor device according toclaim 4, wherein the second criteria set comprises a second primarycriterion based on the first parameter data, a second secondarycriterion based on the second parameter data, and a second tertiarycriterion based on the third parameter data.
 15. The monitor deviceaccording to claim 14, wherein the second criteria set is given by(P_1_1<TH_2_1),(P_2_1<TH_2_2), and(P_3_1>TH_2_3) wherein P_1_1 is a first primary parameter based on thefirst parameter data and indicative of the resistance between the firstelectrode pair, TH_2_1 is a second primary threshold value, P_2_1 is asecond primary parameter based on the second parameter data andindicative of the resistance between the second electrode pair, TH_2_2is a second secondary threshold value, P_3_1 is a third primaryparameter based on the third parameter data and indicative of theresistance between the third electrode pair, TH_2_3 is a second tertiarythreshold value, and wherein the second operating state is indicative ofmedium degree of radial erosion on the base plate.
 16. The monitordevice according to claim 1, wherein the to determine an operating statecomprises to compare the first parameter data and the second parameterdata, and wherein the operating state is based on the comparison betweenthe first parameter data and the second parameter data.
 17. The monitordevice according to claim 1, wherein the second interface comprises aloudspeaker connected to the processor, and wherein the processor isconfigured to transmit a monitor signal via the loudspeaker.
 18. Themonitor device according to claim 1, wherein the second interfacecomprises an antenna and a wireless transceiver, and wherein theprocessor is configured to transmit a monitor signal as a wirelessmonitor signal via the antenna and the wireless transceiver.
 19. Anmedical system comprising an appliance and a monitor device, theappliance comprising a base plate, wherein the monitor device is amonitor device according to claim
 1. 20. A method of monitoring anmedical appliance comprising a base plate, the method comprising: at amonitor device comprising a processor configured to apply a processingscheme; memory; a first interface connected to the processor and thememory; and a second interface connected to the processor: collectingdata from the base plate; applying a processing scheme comprising:obtaining first parameter data based on first data of the data;obtaining second parameter data based on second data of the data;obtaining third parameter data based on third data; and determining anoperating state of the base plate based on the first parameter data, thesecond parameter data and the third parameter data, wherein theoperating state is indicative of a degree of radial erosion of the baseplate and/or acute leakage risk for the appliance; in accordance with adetermination that the operating state is a first operating state,transmitting a first monitor signal comprising monitor data indicativeof the first operating state of the base plate via the second interface;and in accordance with a determination that the operating state is asecond operating state, transmitting a second monitor signal comprisingmonitor data indicative of the second operating state of the base platevia the second interface.